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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K871449
Device Name ONCOLOGY SPT SYS #MS-C10 MEDICATION RESERVOIR BAG
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 Number880.5025
Classification Product Code
KPE  
Date Received04/13/1987
Decision Date 06/17/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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