NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS


Device Classification Name

lens, contact, (disposable)

510(k) Number K112192
Device Name NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS
Applicant
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

Applicant Contact tricia garrett
Correspondent
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

Correspodent Contact tricia garrett
Regulation Number 886.5925
Classification Product Code
MVN  
Date Received 07/29/2011
Decision Date 10/25/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No