|
Device | BOSTON EQUALENS/BOSTON EQUALENS II |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | BAUSCH & LOMB 1400 N. GOODMAN ST. ROCHESTER, NY 14692 |
PMA Number | P860022 |
Supplement Number | S053 |
Date Received | 09/25/2001 |
Decision Date | 11/21/2001 |
Product Code |
MWL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR WET SHIPPING AND UP TO 30 DAYS STORAGE IN BOSTON ADVANCE COMFORT FORMULA CONDITIONING SOLUTION. |