WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)

Electrocautery, Gynecologic (and 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 (proposed).

Pre-market Notification Details

Device IDK983840
510k NumberK983840
Device Name:WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
ClassificationElectrocautery, Gynecologic (and 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 CodeHGI  
CFR Regulation Number884.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-30
Decision Date1999-05-20
Summary:summary

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