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FDA 510(k) Application Details - K982097
Device Classification Name
Needle, Hypodermic, Single Lumen
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510(K) Number
K982097
Device Name
Needle, Hypodermic, Single Lumen
Applicant
WORLDWIDE MEDICAL TECHNOLOGIES, LLC
125 MAIN ST., NORTH
WOODBURY, CT 06798-0505 US
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Contact
GARY LAMOUREUX
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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
06/15/1998
Decision Date
06/25/1998
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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