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FDA 510(k) Application Details - K051694
Device Classification Name
Syringe, Antistick
More FDA Info for this Device
510(K) Number
K051694
Device Name
Syringe, Antistick
Applicant
MEDICAL DEVICE MANUFACTURER (THAILAND) LTD.
7/145 MOO 4
AMATA CITY INDUSTRIAL ESTATE
RAYONG 21140 TH
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Contact
OYTIP KUNWUNLOP
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
06/23/2005
Decision Date
12/21/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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