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FDA 510(k) Application Details - K183681
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K183681
Device Name
Dressing, Wound, Drug
Applicant
Global Health Solutions (DBA Turn Therapeutics)
2362 Calabasas Road #100
Calabasas, CA 91302 US
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Contact
Bradley Burnam
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/28/2018
Decision Date
10/11/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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