510(k) K112192

NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS by Bausch & Lomb, Inc. — Product Code MVN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2011
Date Received
July 29, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, (Disposable)
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type