| Device Classification Name |
system, image management, ophthalmic |
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|---|---|---|---|---|
| 510(k) Number | K110869 | |||
| Device Name | CARA | |||
| Applicant |
|
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| Applicant Contact | aron shapiro | |||
| Correspondent |
|
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| Correspodent Contact | aron shapiro | |||
| Regulation Number | 892.2050 | |||
| Classification Product Code |
|
|||
| Date Received | 03/29/2011 | |||
| Decision Date | 07/14/2011 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Radiology |
|||
| 510k Review Panel |
Ophthalmic |
|||
| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |