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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 K872796
Device Name ADDITIONS TO WSL NITROSPRAY CRYOSURGICAL UNITS
Applicant
Tower Mfg. Co., Inc.
P.O. Box 32336
Nimitz Station
San Antonio,  TX  78216
Applicant Contact F. M SANDLIN
Correspondent
Tower Mfg. Co., Inc.
P.O. Box 32336
Nimitz Station
San Antonio,  TX  78216
Correspondent Contact F. M SANDLIN
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/07/1987
Decision Date 07/23/1987
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
Predetermined Change
Control Plan Authorized		 No
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