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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dilator, esophageal
510(k) Number K884712
Device Name ESOPHAGEAL AND PYLORIC BALLOON DIALATORS
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 Number876.5365
Classification Product Code
KNQ  
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
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