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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 K963348
Device Name WALLACH INTEGRATION UNIT
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 Received08/26/1996
Decision Date 03/19/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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