The following data is part of a premarket notification filed by Cogent Therapeutics, Llc with the FDA for Nasal/epistaxis Pack.
| Device ID | K113585 |
| 510k Number | K113585 |
| Device Name: | NASAL/EPISTAXIS PACK |
| Classification | Splint, Intranasal Septal |
| Applicant | COGENT THERAPEUTICS, LLC 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Contact | Anne Worden |
| Correspondent | Anne Worden COGENT THERAPEUTICS, LLC 3637 BERNAL AVENUE Pleasanton, CA 94566 |
| Product Code | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-05 |
| Decision Date | 2012-04-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10857326005540 | K113585 | 000 |
| 10857326005533 | K113585 | 000 |
| 00857326005543 | K113585 | 000 |
| 00857326005536 | K113585 | 000 |