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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K972810
Device Name OPT80 THE TRANSPORTABLE (OPT80)
Applicant
O.P.T. USA, INC.
235 SACKETT ST.
BROOKLYN,  NY  11231
Applicant Contact MARIA CORIA
Correspondent
O.P.T. USA, INC.
235 SACKETT ST.
BROOKLYN,  NY  11231
Correspondent Contact MARIA CORIA
Regulation Number878.4960
Classification Product Code
FQO  
Date Received07/28/1997
Decision Date 08/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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