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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy, Mechanical, Gastrointestinal
510(k) Number K911155
Device Name OVAL CUP BIOPSY FORCEP
Applicant
ENDOVATIONS
ROSSMOYNE INDUSTRIAL PARK
5020 RITTER ROAD, SUITE 211
MECHANICSBURG,  PA  17055
Applicant Contact JANE E PREDIX
Correspondent
ENDOVATIONS
ROSSMOYNE INDUSTRIAL PARK
5020 RITTER ROAD, SUITE 211
MECHANICSBURG,  PA  17055
Correspondent Contact JANE E PREDIX
Regulation Number876.1075
Classification Product Code
FCF  
Date Received03/15/1991
Decision Date 08/07/1991
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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