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FDA 510(k) Application Details - K002213
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K002213
Device Name
Needle, Hypodermic, Single Lumen
Applicant
HUNTER RESEARCH LABORATORIES, INC.
1541 SOUTH VINE ST.
DENVER, CO 80210 US
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Contact
BARBARA PEDIGO
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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
07/21/2000
Decision Date
10/03/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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