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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryosurgical, accessories
510(k) Number K935010
Device Name WALLACH ULTRA FREEZE
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 Number878.4350
Classification Product Code
GEH  
Date Received10/20/1993
Decision Date 02/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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