Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K053321
Device Classification Name
Light, Surgical, Accessories
More FDA Info for this Device
510(K) Number
K053321
Device Name
Light, Surgical, Accessories
Applicant
XODUS MEDICAL, INC.
702 PROMINENCE DR.
NEW KENSINGTON, PA 15068 US
Other 510(k) Applications for this Company
Contact
CRAIG KAFOREY
Other 510(k) Applications for this Contact
Regulation Number
878.4580
More FDA Info for this Regulation Number
Classification Product Code
FTA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/30/2005
Decision Date
01/19/2006
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