Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K102946
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K102946
Device Name
Dressing, Wound, Collagen
Applicant
CORELEADER BIOTECH CO., LTD.
19F NO. 100, SEC 1
SINTAI 5TH RD, SIJHIH CITY
TAIPEI, TAIWAN 22102 TW
Other 510(k) Applications for this Company
Contact
IAN LI
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/04/2010
Decision Date
05/20/2011
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