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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 K983840
Device Name WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
Applicant
Wallach Surgical Devices, Inc.
235 Edison Rd.
Orange,  CT  06477
Applicant Contact MICHAEL MALIS
Correspondent
Wallach Surgical Devices, Inc.
235 Edison Rd.
Orange,  CT  06477
Correspondent Contact MICHAEL MALIS
Regulation Number884.4120
Classification Product Code
HGI  
Date Received10/30/1998
Decision Date 05/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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