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FDA 510(k) Application Details - K970547
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K970547
Device Name
Needle, Hypodermic, Single Lumen
Applicant
THANTEX SPECIALTIES, INC.
4320 INTERNATIONAL BLVD, NW
NORCROSS, GA 30093 US
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Contact
TOM BONNER
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Regulation Number
880.5570
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Classification Product Code
FMI
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More FDA Info for this Product Code
Date Received
02/12/1997
Decision Date
07/18/1997
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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