FDA 510(k) Application Details - K994253

Device Classification Name Syringe, Piston

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510(K) Number K994253
Device Name Syringe, Piston
Applicant MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095 US
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Contact CHESTER MCCOY
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 12/17/1999
Decision Date 01/05/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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