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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 Ave.S
P.O. Box 6386
Reading,  PA  19610
Applicant Contact RONALD D WOLFE
Correspondent
Endovations
Hill And George Ave.S
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
Predetermined Change
Control Plan Authorized		 No
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