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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tubes, vials, systems, serum separators, blood collection
510(k) Number K120490
Device Name QUICK SAMPLER HOLDER
Original Applicant
NIPRO MEDICAL CORPORATION
3150 n.w. 107th ave.
miami,  FL  33172
Original Contact jessica oswald
Regulation Number862.1675
Classification Product Code
JKA  
Date Received02/17/2012
Decision Date 12/27/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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