Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K131875
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K131875
Device Name
Case, Contact Lens
Applicant
FORESIGHT REGULATORY STRATEGIES
187 BALLARDVALE STREET
SUITE 180
WILMINGTON, MA 01887-4461 US
Other 510(k) Applications for this Company
Contact
Ellen M Beucler
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2013
Decision Date
08/06/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact