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FDA 510(k) Application Details - K212827
Device Classification Name
Patient Examination Glove, Specialty
More FDA Info for this Device
510(K) Number
K212827
Device Name
Patient Examination Glove, Specialty
Applicant
JR Engineering & Medical Technologies (M) SDN.BHD.
Lot 8 &10, Jalan Zurah 3 & Lot 1&3, Jalan Zurah
3A/1, Pusat Perindustrian 2,
Hulu Selangor 44200 MY
Other 510(k) Applications for this Company
Contact
Ganesan Subramaniam
Other 510(k) Applications for this Contact
Regulation Number
880.6250
More FDA Info for this Regulation Number
Classification Product Code
LZC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/03/2021
Decision Date
12/06/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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