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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Infusor, Pressure, For I.V. Bags
510(k) Number K860084
Device Name PRESSURE INFUSOR #1900
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 Number880.5420
Classification Product Code
KZD  
Date Received01/09/1986
Decision Date 03/18/1986
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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