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FDA 510(k) Application Details - K183389
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K183389
Device Name
Surgeon'S Gloves
Applicant
Hartalega NGC Sdn. Bhd.
Kawasan Perindustrian Tanjung
Sepang 43900 MY
Other 510(k) Applications for this Company
Contact
Kuan Leong
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
12/06/2018
Decision Date
06/28/2019
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
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