NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS

Electrosurgical, Cutting & Coagulation & Accessories

AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by American Hydro-surgical Instruments, Inc. with the FDA for Nezhat-dorsey Laparoscopic Hand Instruments.

Pre-market Notification Details

Device IDK950507
510k NumberK950507
Device Name:NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach,  FL  33445
ContactMartine D Schneider
CorrespondentMartine D Schneider
AMERICAN HYDRO-SURGICAL INSTRUMENTS, INC. 430 COMMERCE DR. Delray Beach,  FL  33445
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-06
Decision Date1995-03-06

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