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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name set, administration, intravascular
510(k) Number K913333
Device Name I.V. PRIMING SET
Applicant
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Applicant Contact MARK GAINOR
Correspondent
GAINOR MEDICAL EUROPE, LTD.
P.O. BOX 353
MCDONOUGH,  GA  30253 -0353
Correspondent Contact MARK GAINOR
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/26/1991
Decision Date 10/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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