Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K062385
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K062385
Device Name
Tube, Tympanostomy
Applicant
Grace Medical, Inc.
8500 WOLF LAKE DR., STE. 110
MEMPHIS, TN 38133 US
Other 510(k) Applications for this Company
Contact
JEFF COBB
Other 510(k) Applications for this Contact
Regulation Number
874.3880
More FDA Info for this Regulation Number
Classification Product Code
ETD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/15/2006
Decision Date
09/27/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact