| 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 | DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS |
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| Classification Name | lenses, soft contact, extended wear |
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| Regulation Number | 886.5925 |
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| Applicant | WESLEY JESSEN CORP. |
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| PMA Number | P850072 |
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| Supplement Number | S001 |
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| Date Received | 08/05/1986 |
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| Decision Date | 04/09/1987 |
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| Product Code | |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - color additive |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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