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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name snare, flexible
510(k) Number K940335
Device Name AMERICAN CATHETER POLY-SNARE
Applicant
INTL. MEDICAL, INC.
10061 AMBERWOOD RD.
FORT MYERS,  FL  33913
Applicant Contact PETER H WETTERMANN
Correspondent
INTL. MEDICAL, INC.
10061 AMBERWOOD RD.
FORT MYERS,  FL  33913
Correspondent Contact PETER H WETTERMANN
Regulation Number876.4300
Classification Product Code
FDI  
Date Received01/25/1994
Decision Date 07/21/1994
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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