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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubes, Gastrointestinal (And Accessories)
510(k) Number K881978
Device Name ENTERAL FEEDING TUBES
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 Number876.5980
Classification Product Code
KNT  
Date Received05/11/1988
Decision Date 07/13/1988
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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