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FDA 510(k) Application Details - K980412
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K980412
Device Name
Surgeon'S Gloves
Applicant
KENWELL INTERNATIONAL LTD.
55 NORTHERN BLVD.,SUITE 410
GREAT NECK, NY 11021 US
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Contact
SUSAN D GOLDSTEIN-FALK
Other 510(k) Applications for this Contact
Regulation Number
878.4460
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Classification Product Code
KGO
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More FDA Info for this Product Code
Date Received
02/03/1998
Decision Date
04/08/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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