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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
510(k) Number K953967
FOIA Releasable 510(k) K953967
Device Name ENDOSCOPIC CATHETER
Applicant
Act Medical, Inc.
100 Beaver St.
Waltham,  MA  02154
Applicant Contact JENNA ANDELMAN
Correspondent
Act Medical, Inc.
100 Beaver St.
Waltham,  MA  02154
Correspondent Contact JENNA ANDELMAN
Regulation Number876.1500
Classification Product Code
ODD  
Date Received08/22/1995
Decision Date 01/22/1996
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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