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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
Predetermined Change
Control Plan Authorized		 No
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