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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name apparatus, autotransfusion
510(k) Number K925827
Device Name IMPRAFLO(TM) POST OPERATIVE/DRAIN/REINFUS KIT/CANI
Applicant
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Applicant Contact Joseph J Schwoebel
Correspondent
IMPRA, INC.
1625 WEST 3RD ST.
P.O. BOX 1740
TEMPE,  AZ  85281
Correspondent Contact Joseph J Schwoebel
Regulation Number868.5830
Classification Product Code
CAC  
Date Received11/16/1992
Decision Date 07/29/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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