Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K121407
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K121407
Device Name
Dressing, Wound, Drug
Applicant
O2S, LLC
1500 SPRING GARDEN ST
PHILADELPHIA, PA 19130 US
Other 510(k) Applications for this Company
Contact
DAVID E PETKO, P.E.
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
05/10/2012
Decision Date
07/09/2012
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