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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 K853731
Device Name HEMED NEEDLE SUPPORT CATALOG NO. HAP-XXXX
Applicant
GISH BIOMEDICAL, INC.
2350 S. PULLMAN AVE.
SANTA ANA,  CA  92705
Applicant Contact JEANNE PIERSON
Correspondent
GISH BIOMEDICAL, INC.
2350 S. PULLMAN AVE.
SANTA ANA,  CA  92705
Correspondent Contact JEANNE PIERSON
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/06/1985
Decision Date 10/18/1985
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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