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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, cryophthalmic
510(k) Number K903303
Device Name SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES
Applicant
SPEMBLY MEDICAL LTD.
NEWBURY ROAD
ANDOVER HAMPSHIRE SP10 4DR
ENGLAND,  GB
Applicant Contact R. B COLEMAN
Correspondent
SPEMBLY MEDICAL LTD.
NEWBURY ROAD
ANDOVER HAMPSHIRE SP10 4DR
ENGLAND,  GB
Correspondent Contact R. B COLEMAN
Regulation Number886.4170
Classification Product Code
HPS  
Date Received07/24/1990
Decision Date 10/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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