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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Cholangiography
510(k) Number K870420
Device Name PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY
Applicant
North Coast Medi-Tek
8603 E. Ave.
Mentor,  OH  44060
Applicant Contact THERESA SOKOLOWSKI
Correspondent
North Coast Medi-Tek
8603 E. Ave.
Mentor,  OH  44060
Correspondent Contact THERESA SOKOLOWSKI
Regulation Number878.4200
Classification Product Code
GBZ  
Date Received02/03/1987
Decision Date 04/14/1987
Decision Substantially Equivalent - With Drug (SESD)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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