| Device Classification Name |
mesh, surgical, non-synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator |
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|---|---|---|---|---|
| 510(k) Number | K992159 | |||
| Device Name | SURGISIS SLING | |||
| Applicant |
|
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| Applicant Contact | neal e fearnot | |||
| Correspondent |
|
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| Correspodent Contact | neal e fearnot | |||
| Regulation Number | 878.3300 | |||
| Classification Product Code |
|
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| Subsequent Product Codes |
|
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| Date Received | 06/25/1999 | |||
| Decision Date | 09/23/1999 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
General & Plastic Surgery |
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| 510k Review Panel |
Obstetrics/Gynecology |
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| summary |
summary |
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| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |