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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 K944221
Device Name VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED
Applicant
CRYOSURGERY, INC.
P.O.BOX 50035
NASHVILLE,  TN  37205 -0035
Applicant Contact RONALD A MCDOW
Correspondent
CRYOSURGERY, INC.
P.O.BOX 50035
NASHVILLE,  TN  37205 -0035
Correspondent Contact RONALD A MCDOW
Regulation Number878.4350
Classification Product Code
GEH  
Date Received08/15/1994
Decision Date 12/15/1994
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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