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FDA 510(k) Application Details - K182176
Device Classification Name
Surgeon'S Gloves
More FDA Info for this Device
510(K) Number
K182176
Device Name
Surgeon'S Gloves
Applicant
PT. Medisafe Technologies
JI Batang Kuis, Gg Tambak Rejo Pasar IX, Desa Buntu Bedimbar
Tanjung Morawa, Medan 20362 ID
Other 510(k) Applications for this Company
Contact
Sajeev Joseph
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
08/10/2018
Decision Date
03/28/2019
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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