Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K974224
Device Classification Name
Tube, Shunt, Endolymphatic
More FDA Info for this Device
510(K) Number
K974224
Device Name
Tube, Shunt, Endolymphatic
Applicant
EXMOOR PLASTICS LTD.
LISIEUX WAY
TAUNTON, SOMERSET TA1 2LB GB
Other 510(k) Applications for this Company
Contact
MARGARET BLACKMORE
Other 510(k) Applications for this Contact
Regulation Number
874.3820
More FDA Info for this Regulation Number
Classification Product Code
ESZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/10/1997
Decision Date
01/27/1998
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