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FDA 510(k) Application Details - K223377
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K223377
Device Name
Dressing, Wound, Drug
Applicant
Rochal Technologies LLC
1200 Network Boulevard
Suite B200
San Antonio, TX 78249 US
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Contact
William Coulston
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
11/04/2022
Decision Date
03/30/2023
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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