Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K082985
Device Classification Name
Unit, Operative Dental
More FDA Info for this Device
510(K) Number
K082985
Device Name
Unit, Operative Dental
Applicant
A-DEC, INC.
2601 CRESTVIEW DR.
NEWBERG, OR 97132-9257 US
Other 510(k) Applications for this Company
Contact
THOMAS H LOUISELL
Other 510(k) Applications for this Contact
Regulation Number
872.6640
More FDA Info for this Regulation Number
Classification Product Code
EIA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/07/2008
Decision Date
12/17/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact