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FDA 510(k) Application Details - K201576
Device Classification Name
Latex Patient Examination Glove
More FDA Info for this Device
510(K) Number
K201576
Device Name
Latex Patient Examination Glove
Applicant
PT. Universal Gloves
JL. Pertahanan No.17 Patumbak
Medan 20361 ID
Other 510(k) Applications for this Company
Contact
Sutopo Sutopo
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
06/11/2020
Decision Date
05/19/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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