|
Device | SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION |
Generic Name | Accessories, soft lens products |
Regulation Number | 886.5928 |
Applicant | Bausch & Lomb, Inc. 14853 DEVEAU PLACE MINNETONKA, MN 55345 |
PMA Number | P820031 |
Supplement Number | S014 |
Date Received | 10/10/1996 |
Decision Date | 03/10/1997 |
Product Code |
LPN |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REDUCING THE FILL VOLUME FOR RENU(R) LENS REWETTING DROPS FROM THE CURRENTLY APPROVED 5 ML TO 3 ML IN THE SAME 7.5 ML BOTTLE. |