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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 K970995
Device Name CMS CRYOLITE
Applicant
CRYOMEDICAL SCIENCES, INC.
1300 PICCARD DR.
ROCKVILLE,  MD  20850
Applicant Contact RICHARD J REINHART
Correspondent
CRYOMEDICAL SCIENCES, INC.
1300 PICCARD DR.
ROCKVILLE,  MD  20850
Correspondent Contact RICHARD J REINHART
Regulation Number878.4350
Classification Product Code
GEH  
Date Received03/19/1997
Decision Date 07/07/1997
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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