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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, circular (spiral), scalp and applicator
510(k) Number K844608
Device Name SURGICRAFT COPELAND DISPOSABLE
Applicant
A.W. SHOWELL (SURGICRAFT) LTD.
BRITTEN ST.
REDDITCH
WORCS. B97 6HF ENGLAND,  GB
Applicant Contact SHOWELL
Correspondent
A.W. SHOWELL (SURGICRAFT) LTD.
BRITTEN ST.
REDDITCH
WORCS. B97 6HF ENGLAND,  GB
Correspondent Contact SHOWELL
Regulation Number884.2675
Classification Product Code
HGP  
Date Received11/27/1984
Decision Date 05/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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