Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K964240
Device Classification Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
More FDA Info for this Device
510(K) Number
K964240
Device Name
Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Applicant
MEDIX PHARMACEUTICALS AMERICAS, INC.
1050 CONNECTICUT AVENUE, N.W.
WASHINGTON, DC 20036 US
Other 510(k) Applications for this Company
Contact
WAYNE H MATELSKI
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
10/24/1996
Decision Date
01/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact