510(k) K760273
- Device
- LITHOTRITE
- Applicant
- V. Mueller O.V. Baxter Healthcare Corp.
- 510(k) number
- K760273
- Product code
- FGK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1976-12-06
- Date received
- 1976-07-22
- Regulation
- 876.4500
- Classification name
- Tripsor, Stone, Bladder
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2243757
Source Documents#
510(k) summary PDF not indicated by FDA