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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K844305
Device Name GAINOR MEDICAL FLOWMAX NEEDLES
Applicant
Gainor Medical
12520 Yellowhead Trl.
Applicant Contact MARK GAINOR
Correspondent
Gainor Medical
12520 Yellowhead Trl.
Correspondent Contact MARK GAINOR
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/06/1984
Decision Date 11/30/1984
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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