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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocautery, gynecologic (and accessories)
510(k) Number K963653
Device Name WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
Applicant
WALLACH SURGICAL DEVICES, INC.
291 PEPE'S FARM RD.
MILFORD,  CT  06460
Applicant Contact RAYMOND A WILEY
Correspondent
WALLACH SURGICAL DEVICES, INC.
291 PEPE'S FARM RD.
MILFORD,  CT  06460
Correspondent Contact RAYMOND A WILEY
Regulation Number884.4120
Classification Product Code
HGI  
Date Received09/12/1996
Decision Date 06/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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