SPECIMEN RETRIEVAL BAG

Laparoscope, General & Plastic Surgery

APPLIED MEDICAL RESOURCES

The following data is part of a premarket notification filed by Applied Medical Resources with the FDA for Specimen Retrieval Bag.

Pre-market Notification Details

Device IDK962395
510k NumberK962395
Device Name:SPECIMEN RETRIEVAL BAG
ClassificationLaparoscope, General & Plastic Surgery
Applicant APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
ContactHoward V Rowe
CorrespondentHoward V Rowe
APPLIED MEDICAL RESOURCES 26051 MERIT CIRCLE BUILDING 104 Laguna Hills,  CA  92653
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-20
Decision Date1996-07-05
Summary:summary

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