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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 K881349
Device Name VERRUCA-FREEZE(TM) CRYOTHERAPY DELIVERY SYSTEM
Applicant
Cryosurg, Inc.
7356 Cabot Dr.
Nashville,  TN  37209
Applicant Contact MCDOW, MD
Correspondent
Cryosurg, Inc.
7356 Cabot Dr.
Nashville,  TN  37209
Correspondent Contact MCDOW, MD
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/30/1988
Decision Date 06/30/1988
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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