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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, surgical, accessories
510(k) Number K882132
Device Name LIGHT, SURGICAL ACCESSORIES
Applicant
CHARLES POLO & CO., INC.
P.O. BOX 227
W. HENRIETTA,  NY  14586
Applicant Contact JACK SCOVILLE
Correspondent
CHARLES POLO & CO., INC.
P.O. BOX 227
W. HENRIETTA,  NY  14586
Correspondent Contact JACK SCOVILLE
Regulation Number878.4580
Classification Product Code
FTA  
Date Received05/20/1988
Decision Date 06/15/1988
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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