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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 K910673
Device Name BAG SPIGOT
Applicant
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Applicant Contact BOB EVERETT
Correspondent
Procedure Products, Inc.
1801 W. 4th Plain Blvd.
Vancouver,  WA  98660
Correspondent Contact BOB EVERETT
Regulation Number880.5025
Classification Product Code
KPE  
Date Received02/15/1991
Decision Date 04/24/1991
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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