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FDA 510(k) Application Details - K211621
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K211621
Device Name
Surgeon'S Gloves
Applicant
Careplus (M) SDN BHD
Lot 120 & 121, Jalan Senawang 3, Senawang Industrial Estate
Seremban 70450 MY
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Contact
Lim Kwee Shyan
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
05/26/2021
Decision Date
10/06/2021
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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