Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K062842
Device Classification Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
More FDA Info for this Device
510(K) Number
K062842
Device Name
Drills, Burrs, Trephines & Accessories (Simple, Powered)
Applicant
WALTER LORENZ SURGICAL, INC.
1520 TRADEPORT DR.
JACKSONVILLE, FL 32218 US
Other 510(k) Applications for this Company
Contact
KIM REED
Other 510(k) Applications for this Contact
Regulation Number
882.4310
More FDA Info for this Regulation Number
Classification Product Code
HBE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2006
Decision Date
12/04/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact