Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K080680
Device Classification Name
Suture, Surgical, Absorbable, Polydioxanone
More FDA Info for this Device
510(K) Number
K080680
Device Name
Suture, Surgical, Absorbable, Polydioxanone
Applicant
SURGICAL SPECIALTIES CORP.
13921 PARK CENTER RD.
SUITE 200
HERNDON, VA 20171 US
Other 510(k) Applications for this Company
Contact
TRUDY D ESTRIDGE
Other 510(k) Applications for this Contact
Regulation Number
878.4840
More FDA Info for this Regulation Number
Classification Product Code
NEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/10/2008
Decision Date
03/21/2008
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