FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
K Number: K982042
·
Decision Sep 8, 1998
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
- K Number
- K982042
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Island Biosurgical, Inc.
- Date Received
- June 10, 1998
- Decision Date
- September 8, 1998
- Product Code
- OTN
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | FDA class 2 | General, Plastic Surgery |
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