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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endoscopic injection needle, gastroenterology-urology
510(k) Number K883093
Device Name TRANSENDOSCOPIC ASPIRATION NEEDLE
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 Number876.1500
Classification Product Code
FBK  
Date Received07/22/1988
Decision Date 12/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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