510(k) K954972
- Device
- LYELL SOUND
- Applicant
- Venture Management Corp.
- 510(k) number
- K954972
- Product code
- FBS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-01-24
- Date received
- 1995-10-27
- Regulation
- 876.4590
- Classification name
- Sound, Metal, Interconnected
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- GENE ZAMBA
- Address
- 2323 Curlew Rd. Suite 2-E Palm Harbor FL US 34683 34683
FDA Registration Numbers#
- 1417592
- 1836161
- 8040278
- 3001644167
- 3005528784
- 3004215117
- 1421101
- 8030607
Source Documents#
510(k) summary PDF not indicated by FDA