Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K012126
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
More FDA Info for this Device
510(K) Number
K012126
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
CARRINGTON LABORATORIES, INC.
2001 WALNUT HILL LN.
IRVING, TX 75038 US
Other 510(k) Applications for this Company
Contact
KENNETH M YATES
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
MGQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/06/2001
Decision Date
10/03/2001
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