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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 K884709
FOIA Releasable 510(k) K884709
Device Name ENDOSCOPES & ACCESS.(SCLEROTHERAPY/TRANSBRONCHIAL)
Applicant
PRIMROSE MEDICAL, INC.
20 CABOT RD.
WOBURN,  MA  01801
Applicant Contact FLETCHER LONGLEY
Correspondent
PRIMROSE MEDICAL, INC.
20 CABOT RD.
WOBURN,  MA  01801
Correspondent Contact FLETCHER LONGLEY
Regulation Number876.1500
Classification Product Code
ODD  
Subsequent Product Codes
FAD   FBK   FDI   FDX   KNS  
Date Received11/08/1988
Decision Date 09/08/1989
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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