Disposable Standard Clamp

Laparoscope, General & Plastic Surgery

Standard Bariatrics

The following data is part of a premarket notification filed by Standard Bariatrics with the FDA for Disposable Standard Clamp.

Pre-market Notification Details

Device IDK170379
510k NumberK170379
Device Name:Disposable Standard Clamp
ClassificationLaparoscope, General & Plastic Surgery
Applicant Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati,  OH  45242
ContactAlison Sathe
CorrespondentAlison Sathe
Standard Bariatrics 4362 Glendale Milford Rd. Cincinnati,  OH  45242
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-07
Decision Date2017-07-19
Summary:summary

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