Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K183645
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K183645
Device Name
Dressing, Wound, Drug
Applicant
Advanced Medical Solutions Ltd.
Premier Park, 33 , Winsford Industrial Estate
Winsford CW7 3RT GB
Other 510(k) Applications for this Company
Contact
Amy Turner
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
12/26/2018
Decision Date
05/29/2019
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact