information about
Device Classification Name |
mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed |
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510(k) Number | K002233 | |||
Device Name | BVI SLING | |||
Original Applicant |
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Original Contact | daisy p sin | |||
Regulation Number | 878.3300 | |||
Classification Product Code |
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Date Received | 07/24/2000 | |||
Decision Date | 10/13/2000 | |||
Decision |
substantially equivalent (SESE) |
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Regulation Medical Specialty |
General & Plastic Surgery |
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510k Review Panel |
General & Plastic Surgery |
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Type | Traditional | |||
Reviewed by Third Party | No | |||
Combination Product |
No |
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Recalls | CDRH Recalls |