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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 K896724
Device Name CRYOJET LIQUID NITROGEN SPRAY CRYOSURGICAL INSTRU.
Applicant
STIEFEL RESEARCH INSTITUTE, INC.
OAK HILL,  NY  12460
Applicant Contact CARR, JR
Correspondent
STIEFEL RESEARCH INSTITUTE, INC.
OAK HILL,  NY  12460
Correspondent Contact CARR, JR
Regulation Number878.4350
Classification Product Code
GEH  
Date Received11/29/1989
Decision Date 01/09/1990
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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