FDA 510(k) Application Details - K973792

Device Classification Name Syringe, Antistick

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510(K) Number K973792
Device Name Syringe, Antistick
Applicant SAF-T-MED, INC.
1250 SOUTH GROVE, SUITE 200
BARRINGTON, IL 60010-5011 US
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Contact JAMES ERBS
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Regulation Number 880.5860

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Classification Product Code MEG
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Date Received 10/06/1997
Decision Date 01/29/1998
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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