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FDA 510(k) Application Details - K211275
Device Classification Name
Mask, Surgical
More FDA Info for this Device
510(K) Number
K211275
Device Name
Mask, Surgical
Applicant
PremiumEStore, LLC
2601 Reliance Drive, Suite 102
Virginia Beach, VA 23452 US
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Contact
Brent Dillie
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Regulation Number
878.4040
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Classification Product Code
FXX
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More FDA Info for this Product Code
Date Received
04/27/2021
Decision Date
05/25/2021
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
Y
Expedited Review
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