Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K071178
Device Classification Name
Tube, Tympanostomy
More FDA Info for this Device
510(K) Number
K071178
Device Name
Tube, Tympanostomy
Applicant
OTOMEDICS ADVANCED MEDICAL TECHNOLOGIES, LTD.
20 HATA'AS ST.
KFAR SABA 44425 IL
Other 510(k) Applications for this Company
Contact
AHAVA STEIN
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
04/27/2007
Decision Date
06/22/2007
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