Device Classification Name |
system,in-office tinting,contact lenses |
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---|---|---|---|---|
510(k) Number | K991995 | |||
Device Name | SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS | |||
Applicant |
|
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Applicant Contact | martin dalsing | |||
Correspondent |
|
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Correspodent Contact | martin dalsing | |||
Regulation Number | 886.5925 | |||
Classification Product Code |
|
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Date Received | 06/14/1999 | |||
Decision Date | 08/27/1999 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
Ophthalmic |
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510k Review Panel |
Ophthalmic |
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summary |
summary |
|||
Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |