| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | SOFTLENS(R) (POLYMACON) CONTACT LENSES |
| Classification Name | lenses, soft contact, extended wear |
| Generic Name | soft contact lens |
| Regulation Number | 886.5925 |
| Applicant | BAUSCH & LOMB, INC. |
| PMA Number | N16895 |
| Supplement Number | S075 |
| Date Received | 05/10/1991 |
| Decision Date | 08/08/1991 |
| Product Code | |
| Advisory Committee |
Ophthalmic |
| Supplement Type | normal 180 day track |
| Supplement Reason | change design/components/specifications - other |
| Expedited Review Granted? | No |
| Combination Product |
No
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