FDA 510(k) Application Details - K990831

Device Classification Name Syringe, Antistick

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510(K) Number K990831
Device Name Syringe, Antistick
Applicant U.S. SAFETY SYRINGES CO., INC.
1290 EAST OAKLAND PARK BLVD.
SUITE 200
FORT LAUDERDALE, FL 33334-4447 US
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Contact JAMES GINESI
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 03/12/1999
Decision Date 03/08/2000
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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