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FDA 510(k) Application Details - K981184
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K981184
Device Name
Needle, Hypodermic, Single Lumen
Applicant
BFI- MEDICAL WASTE SYSTEMS
700 THIRTEENTH ST. N.W.
SUITE 1200
WASHINGTON, DC 20005 US
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Contact
A W SIEGNER
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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
04/01/1998
Decision Date
06/22/1998
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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