Tissue Removal Pouch

Laparoscope, General & Plastic Surgery

BOEHRINGER LABORATORIES, LLC

The following data is part of a premarket notification filed by Boehringer Laboratories, Llc with the FDA for Tissue Removal Pouch.

Pre-market Notification Details

Device IDK150781
510k NumberK150781
Device Name:Tissue Removal Pouch
ClassificationLaparoscope, General & Plastic Surgery
Applicant BOEHRINGER LABORATORIES, LLC 300 Thoms Drive Phoenixville,  PA  19460
ContactChris Radl
CorrespondentChris Radl
BOEHRINGER LABORATORIES, LLC 300 Thoms Drive Phoenixville,  PA  19460
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-25
Decision Date2015-06-19
Summary:summary

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