HSV LAPAROSCOPY SET

Laparoscope, General & Plastic Surgery

HENKE SASS WOLF OF AMERICA, INC.

The following data is part of a premarket notification filed by Henke Sass Wolf Of America, Inc. with the FDA for Hsv Laparoscopy Set.

Pre-market Notification Details

Device IDK941541
510k NumberK941541
Device Name:HSV LAPAROSCOPY SET
ClassificationLaparoscope, General & Plastic Surgery
Applicant HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge,  MA  01550
ContactRandall Chinnock
CorrespondentRandall Chinnock
HENKE SASS WOLF OF AMERICA, INC. SOROCO INDUSTRIAL PARK ROUTE 131 Southbridge,  MA  01550
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-03-29
Decision Date1994-05-16

NIH GUDID Devices

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