Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K101168
Device Classification Name
Motor, Drill, Pneumatic
More FDA Info for this Device
510(K) Number
K101168
Device Name
Motor, Drill, Pneumatic
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
Other 510(k) Applications for this Company
Contact
THERESA LEISTER
Other 510(k) Applications for this Contact
Regulation Number
882.4370
More FDA Info for this Regulation Number
Classification Product Code
HBB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/2010
Decision Date
08/24/2010
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