The following data is part of a premarket notification filed by Helix Medical, Llc with the FDA for Blom-singer Septal Perforation Prosthesis.
| Device ID | K131745 |
| 510k Number | K131745 |
| Device Name: | BLOM-SINGER SEPTAL PERFORATION PROSTHESIS |
| Classification | Button, Nasal Septal |
| Applicant | HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria, CA 93013 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria, CA 93013 |
| Product Code | LFB |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-13 |
| Decision Date | 2013-09-17 |
| Summary: | summary |