Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K991630
Device Classification Name
Elastomer, Silicone, For Scar Management
More FDA Info for this Device
510(K) Number
K991630
Device Name
Elastomer, Silicone, For Scar Management
Applicant
ADVANCED MEDICAL SOLUTIONS GROUP PLC
ROAD THREE,
WINFORD INDUSTRIAL ESTATE
WINSFORD, CHESHIRE CW7 3PD GB
Other 510(k) Applications for this Company
Contact
CHRIS OAKES
Other 510(k) Applications for this Contact
Regulation Number
878.4025
More FDA Info for this Regulation Number
Classification Product Code
MDA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/11/1999
Decision Date
06/11/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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