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FDA 510(k) Application Details - K001098
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K001098
Device Name
Needle, Hypodermic, Single Lumen
Applicant
PRO. DUCT HEALTH, INC.
1360 WILLOW ROAD, SUITE 201
MENLO PARK, CA 94025 US
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Contact
ANGELA B SOITO
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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
04/04/2000
Decision Date
05/18/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
PA - Pathology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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