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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
Other 510(k) Applications for this Contact
Regulation Number
880.5860
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Classification Product Code
MEG
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More FDA Info for this Product Code
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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