SURGICAL OBTURATOR WITH SEAL

Laparoscope, General & Plastic Surgery

APPLIED VASCULAR DEVICES, INC.

The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Surgical Obturator With Seal.

Pre-market Notification Details

Device IDK911730
510k NumberK911730
Device Name:SURGICAL OBTURATOR WITH SEAL
ClassificationLaparoscope, General & Plastic Surgery
Applicant APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills,  CA  92653
ContactJo Stegwell
CorrespondentJo Stegwell
APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills,  CA  92653
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-17
Decision Date1991-12-23

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