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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name unit, electrosurgical, endoscopic (with or without accessories)
510(k) Number K934315
Device Name ENDOVATIONS(R) .035 PRE-CUT PAPILLATOME
Applicant
ENDOVATIONS
HILL AND GEORGE AVENUES
P.O. BOX 6386
READING,  PA  19610
Applicant Contact RONALD D WOLFE
Correspondent
ENDOVATIONS
HILL AND GEORGE AVENUES
P.O. BOX 6386
READING,  PA  19610
Correspondent Contact RONALD D WOLFE
Regulation Number876.4300
Classification Product Code
KNS  
Date Received09/01/1993
Decision Date 02/28/1994
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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