Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113118
Device Classification Name
Lacrimal Stents And Intubation Sets
More FDA Info for this Device
510(K) Number
K113118
Device Name
Lacrimal Stents And Intubation Sets
Applicant
QUEST MEDICAL, INC.
ONE ALLENTOWN PKWY.
ALLEN, TX 75002 US
Other 510(k) Applications for this Company
Contact
AMY CLENDENING-WHEELER
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
OKS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2011
Decision Date
07/31/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact