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 |