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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Surgical Instrument, Disposable
510(k) Number K874063
Device Name ENTERON ABDOMINAL PARACENTESIS TRAY
Applicant
ENDOVATIONS
895 POPLAR CHURCH RD.
CAMP HILL,  PA  17011
Applicant Contact SUSAN P BJORKMAN
Correspondent
ENDOVATIONS
895 POPLAR CHURCH RD.
CAMP HILL,  PA  17011
Correspondent Contact SUSAN P BJORKMAN
Regulation Number878.4800
Classification Product Code
KDD  
Date Received10/05/1987
Decision Date 12/04/1987
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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