Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K111741
Device Classification Name
Instrument, Ultrasonic Surgical
More FDA Info for this Device
510(K) Number
K111741
Device Name
Instrument, Ultrasonic Surgical
Applicant
INTEGRA BURLINGTON MA, INC. (FORMERLY INTEGRA RADI
22 Terry Ave
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Contact
KEVIN J O'CONNELL
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/21/2011
Decision Date
08/23/2011
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