BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS


Device Classification Name

lens, contact (other material) – daily

510(k) Number K073184
Device Name BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
Applicant
BAUSCH & LOMB, INC.
1400 north goodman st.
rochester, 
NY 
14609 -3547

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

Correspodent Contact debra ketchum
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 11/13/2007
Decision Date 02/21/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No