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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 K882963
FOIA Releasable 510(k) K882963
Device Name SPEMBLY MEDICAL 142 CRYO UNIT
Applicant
Spembly Medical , Ltd.
Newbury Rd.
Andover Hampshire Sp10 4dr
England,  GB
Applicant Contact GORDON COOK
Correspondent
Spembly Medical , Ltd.
Newbury Rd.
Andover Hampshire Sp10 4dr
England,  GB
Correspondent Contact GORDON COOK
Regulation Number878.4350
Classification Product Code
GEH  
Date Received07/14/1988
Decision Date 08/08/1988
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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