Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K063007
Device Classification Name
Handpiece, Direct Drive, Ac-Powered
More FDA Info for this Device
510(K) Number
K063007
Device Name
Handpiece, Direct Drive, Ac-Powered
Applicant
WESTPORT MEDICAL, INC.
6603 RIPPLING BROOK DRIVE SE
SALEM, OR 97317 US
Other 510(k) Applications for this Company
Contact
RALPH WELLS
Other 510(k) Applications for this Contact
Regulation Number
872.4200
More FDA Info for this Regulation Number
Classification Product Code
EKX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/02/2006
Decision Date
10/17/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact