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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 K935634
Device Name WALLACH LEEP PROCEDURE KIT
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 Received11/23/1993
Decision Date 07/20/1994
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
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