510(k) K960081
- Device
- BATTERY POWERED ENDOSCCOPIC LIGHT SOURCE
- Applicant
- MITSUBISHI CABLE AMERICA, INC.
- 510(k) number
- K960081
- Product code
- FCQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-03-12
- Date received
- 1996-01-11
- Regulation
- 876.1500
- Classification name
- Light Source, Incandescent, Diagnostic
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RONALD J EHMSEN
- Address
- 10551 Wulff Dr. Villa Park CA US 92667 92667
FDA Registration Numbers#
- 3014409527
Source Documents#
Legacy Summary#
summary
FDA Review#
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