BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS


Device Classification Name

lens, contact (other material) – daily

510(k) Number K022128
Device Name BOSTON EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Original Applicant
BAUSCH & LOMB INCORPORATED
1400 north goodman st.
rochester, 
NY 
14609

Original Contact debra l ketchum
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 07/01/2002
Decision Date 08/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ophthalmic

510k Review Panel

Ophthalmic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No