FDA 510(k) Application Details - K852443

Device Classification Name Syringe, Piston

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510(K) Number K852443
Device Name Syringe, Piston
Applicant PHARMA-PLAST USA, INC.
1801 MCGILL COLLEGE AVE.
SUITE 1470, MONTREAL
CANADA H3A 2N4 CA
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Contact DOUGLAS M BENNETT
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 06/10/1985
Decision Date 10/16/1985
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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