ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
FDA 510(k) clearance K982042 · decided 1998-09-08
Clearance details
- K-number
- K982042
- Device name
- ISLAND BIOSURGICAL BLADDER NECK BOLSTR MODEL IBIBOL.002
- Applicant
- Island Biosurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-10
- Decision date
- 1998-09-08
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mercer Island, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.