Device Classification Name |
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, retropubic or transobturator |
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510(k) Number | K111219 | |||
Device Name | GMD UNIVERSAL URINARY INCONTINENCE SLING | |||
Applicant |
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Applicant Contact | jeff morgan | |||
Correspondent |
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Correspodent Contact | jeff morgan | |||
Regulation Number | 878.3300 | |||
Classification Product Code |
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Date Received | 05/02/2011 | |||
Decision Date | 06/30/2011 | |||
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 |