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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 K853309
Device Name P.A. ENTERAL FEEDING BAG 1100
Applicant
Pa Medical Corp.
1512 Nashville Hwy.
P.O. Box 1286
Columbia,  TN  38401
Applicant Contact BAILEY VAUGHN
Correspondent
Pa Medical Corp.
1512 Nashville Hwy.
P.O. Box 1286
Columbia,  TN  38401
Correspondent Contact BAILEY VAUGHN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/07/1985
Decision Date 08/27/1985
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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