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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 K894374
Device Name BLOOD DRAWING NEEDLE
Applicant
PHARMA-PLAST USA, INC.
26133 US 19 N
CLEARWATER,  FL  34623
Applicant Contact LINDEMANN, BOC
Correspondent
PHARMA-PLAST USA, INC.
26133 US 19 N
CLEARWATER,  FL  34623
Correspondent Contact LINDEMANN, BOC
Regulation Number880.5570
Classification Product Code
FMI  
Date Received07/17/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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