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FDA 510(k) Application Details - K211478
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K211478
Device Name
Surgeon'S Gloves
Applicant
Aspen Glove Sdn. Bhd.
Aspen House, 300, JLN Macalister
Georgetown 10450 MY
Other 510(k) Applications for this Company
Contact
Iskandar Basha bin Abdul Kadir
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
05/12/2021
Decision Date
09/16/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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