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FDA 510(k) Application Details - K984512
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K984512
Device Name
Surgeon'S Gloves
Applicant
CT INTL.
4349 SANTA FE RD.
SAN LUIS OBISPO, CA 93401 US
Other 510(k) Applications for this Company
Contact
MIKE KYLE
Other 510(k) Applications for this Contact
Regulation Number
878.4460
More FDA Info for this Regulation Number
Classification Product Code
KGO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/1998
Decision Date
07/12/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Y
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