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FDA 510(k) Application Details - K203705
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K203705
Device Name
Latex Patient Examination Glove
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
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LYY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/18/2020
Decision Date
08/20/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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