EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION


Device Classification Name

accessories, soft lens products

510(k) Number K111877
Device Name EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION
Applicant
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

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

Correspodent Contact heather michaels
Regulation Number 886.5928
Classification Product Code
LPN  
Date Received 07/01/2011
Decision Date 01/24/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No