FDA 510(k) Application Details - K950666

Device Classification Name Syringe, Piston

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510(K) Number K950666
Device Name Syringe, Piston
Applicant UNIQUE MANAGEMENT ENT., INC.
209 SCHOOLHOUSE RD.
ALBANY, NY 12203-5956 US
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Contact THOMAS E FERARI
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Regulation Number 880.5860

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Classification Product Code FMF
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Date Received 02/13/1995
Decision Date 02/16/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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