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FDA 510(k) Application Details - K213136
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K213136
Device Name
Mask, Surgical
Applicant
Control Print Limited
Village Bhatian, Near TVS Factory, Bharatgarh Road, Nalagarh
District Solan 174101 IN
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Contact
Pankaj Sharma
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FXX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2021
Decision Date
12/24/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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