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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 ROAD
ANDOVER HAMPSHIRE SP10 4DR
ENGLAND,  GB
Applicant Contact GORDON COOK
Correspondent
SPEMBLY MEDICAL LTD.
NEWBURY ROAD
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
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