FDA 510(k) Application Details - K982018

Device Classification Name Syringe, Piston

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510(K) Number K982018
Device Name Syringe, Piston
Applicant MINRAD, INC.
6576 EAST QUAKER ST.
ORCHARD PARK, NY 14127-2593 US
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Contact JOHN MCNEIRNEY
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 06/08/1998
Decision Date 08/07/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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