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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K873748
Device Name RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT
Applicant
DEKNATEL, INC.
2300 MARCUS AVE.
LAKE SUCCESS,  NY  11042
Applicant Contact OROFINO
Correspondent
DEKNATEL, INC.
2300 MARCUS AVE.
LAKE SUCCESS,  NY  11042
Correspondent Contact OROFINO
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/16/1987
Decision Date 01/06/1988
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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