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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 K942068
Device Name AMERICAN CATHETER SPHINCTEROTOME
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
KNS  
Date Received04/29/1994
Decision Date 06/24/1994
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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