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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 K834414
FOIA Releasable 510(k) K834414
Device Name ERCP CANNULA
Applicant
Hobbs Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Hobbs Medical, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
ODD  
Date Received12/15/1983
Decision Date 02/04/1984
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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