Product code FBS
- Device name
- Sound, Metal, Interconnected
- Medical specialty
- Gastroenterology, Urology
- Device class
- 1
- Regulation number
- 876.4590
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954972 | LYELL SOUND | Venture Management Corp. | 1996-01-24 |
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|---|---|---|---|
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