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FDA 510(k) Application Details - K220286
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K220286
Device Name
Dressing, Wound, Drug
Applicant
V3bio Sdn. Bhd
No 18 Jalan Cassia Selatan 3/1 Taman Perindustrian Batu
Kawan Bandar Cassia
Simpang Ampat 14100 MY
Other 510(k) Applications for this Company
Contact
Shudipta Choudhury
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
02/01/2022
Decision Date
12/21/2022
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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