Mary M. Sorg (An Individual) Dba PJ Sleeper'S: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Mary M. Sorg (An Individual) Dba PJ Sleeper'S”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OTX | Foot Wrap For Treating Restless Leg Syndrome Symptoms | 1 | 0 |
Review panels
- Neurology (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN110009 | De Novo | Foot Wrap For Treating Restless Leg Syndrome Symptoms | 2013-12-18 |
Recalls
openFDA lists no recalls under a recalling firm named Mary M. Sorg (An Individual) Dba PJ Sleeper'S.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mary M. Sorg (An Individual) Dba PJ Sleeper'S?
FDA lists 0 510(k) clearances under the applicant name “Mary M. Sorg (An Individual) Dba PJ Sleeper'S”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Mary M. Sorg (An Individual) Dba PJ Sleeper'S?
The most frequent FDA product codes under this applicant name are OTX (Foot Wrap For Treating Restless Leg Syndrome Symptoms, 1).
Next steps
- See all 0 Mary M. Sorg (An Individual) Dba PJ Sleeper'S clearances with predicates and recalls
- Run predicate analysis for product code OTX, Mary M. Sorg (An Individual) Dba PJ Sleeper'S's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.