The following data is part of a premarket notification filed by Helix Medical, Llc with the FDA for Blom-singer Adjustable Bi-fianged Fistula Prosthesis.
| Device ID | K130736 |
| 510k Number | K130736 |
| Device Name: | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria, CA 93013 |
| Contact | Thomas M Vassallo |
| Correspondent | Thomas M Vassallo HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria, CA 93013 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-18 |
| Decision Date | 2013-12-17 |
| Summary: | summary |