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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase-Esterase, Enzymatic, Photometric, Lipase
510(k) Number K874027
Device Name LIPASE UV [TOYO]
Applicant
Advocacy International, Ltd.
Internationa Sq.
1825 Eye St. NW Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Advocacy International, Ltd.
Internationa Sq.
1825 Eye St. NW Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number862.1465
Classification Product Code
CHI  
Date Received10/02/1987
Decision Date 05/27/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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