| 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 | COOPERVISION, INC. HYDRASOFT, HYDRASOFT TORIC, HYDRASOFT XW AND HYDRASOFT TORIC XW (METHAFILCON B) SOFT (HYDROPHILIC)... |
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| Classification Name | lenses, soft contact, extended wear |
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| Generic Name | soft hydrophilic contact lenses |
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| Regulation Number | 886.5925 |
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| Applicant | COOPER VISION, INC. |
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| PMA Number | P850079 |
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| Supplement Number | S042 |
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| Date Received | 05/03/2005 |
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| Decision Date | 06/14/2005 |
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| Product Code | |
| Advisory Committee |
Ophthalmic |
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| Supplement Type | normal 180 day track no user fee |
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| Supplement Reason | location change: manufacturer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for a manufacturing site located at coopervision, inc. , scottsville, new york. |
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