Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080836
Device Classification Name
Mesh, Surgical, Polymeric
More FDA Info for this Device
510(K) Number
K080836
Device Name
Mesh, Surgical, Polymeric
Applicant
ENDOGUN MEDICAL SYSTEMS
JABOTINSKY STREET 7
RAMAT GAN 52520 IL
Other 510(k) Applications for this Company
Contact
DORIT WINITZ
Other 510(k) Applications for this Contact
Regulation Number
878.3300
More FDA Info for this Regulation Number
Classification Product Code
FTL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/25/2008
Decision Date
04/21/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact