510(k) K893874
- Device
- FUJITENS III
- Applicant
- ALTOONA MEDICAL SUPPLY
- 510(k) number
- K893874
- Product code
- GZQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-12-22
- Date received
- 1989-05-26
- Regulation
- 882.4275
- Classification name
- Instrument, Dowel Cutting
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD MACKENZIE
- Address
- 705 2nd Ave., SW Altoona IA US 50009 50009
FDA Registration Numbers#
- 8010303
- 9615033
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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