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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 K980670
Device Name CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
Applicant
CRYOMEDICAL SCIENCES, INC.
1300 PICCARD DR.
ROCKVILLE,  MD  20850
Applicant Contact RICHARD J REINHART PH.D.
Correspondent
CRYOMEDICAL SCIENCES, INC.
1300 PICCARD DR.
ROCKVILLE,  MD  20850
Correspondent Contact RICHARD J REINHART PH.D.
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
OCL  
Date Received02/20/1998
Decision Date 07/17/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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