BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS

Instrument, Ent Manual Surgical

HELIX MEDICAL, LLC

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.

Pre-market Notification Details

Device IDK130736
510k NumberK130736
Device Name:BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
ClassificationInstrument, Ent Manual Surgical
Applicant HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria,  CA  93013
ContactThomas M Vassallo
CorrespondentThomas M Vassallo
HELIX MEDICAL, LLC 1110 MARK AVE. Carpinteria,  CA  93013
Product CodeLRC  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-18
Decision Date2013-12-17
Summary:summary

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