| Device Classification Name |
monitor, ultrasonic, nonfetal |
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|---|---|---|---|---|
| 510(k) Number | K081429 | |||
| Device Name | THD SLIDE | |||
| Applicant |
|
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| Applicant Contact | maureen o’connell | |||
| Correspondent |
|
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| Correspodent Contact | maureen o’connell | |||
| Regulation Number | 892.1540 | |||
| Classification Product Code |
|
|||
| Date Received | 05/21/2008 | |||
| Decision Date | 07/30/2008 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Radiology |
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| 510k Review Panel |
General & Plastic Surgery |
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| summary |
summary |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |