WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

Electrosurgical, Cutting & Coagulation & Accessories

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Wallach Quantum 500 Electrosurgical Generator.

Pre-market Notification Details

Device IDK983208
510k NumberK983208
Device Name:WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange,  CT  06477
ContactMichael Malis
CorrespondentMichael Malis
WALLACH SURGICAL DEVICES, INC. 235 EDISON RD. Orange,  CT  06477
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-14
Decision Date1999-02-22

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