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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 K972536
Device Name SYRINGE NEEDLE REMOVER (S.N.R.)
Applicant
POST MEDICAL, INC.
P.O. BOX 29863
ATLTANTA,  GA  30359
Applicant Contact DAVID R THEAD
Correspondent
POST MEDICAL, INC.
P.O. BOX 29863
ATLTANTA,  GA  30359
Correspondent Contact DAVID R THEAD
Regulation Number880.5570
Classification Product Code
FMI  
Date Received06/08/1997
Decision Date 08/15/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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