510(k) K970510
- Device
- INNOFLOUR TOPIRAMATE REAGENT SET
- Applicant
- OXIS INTL., INC.
- 510(k) number
- K970510
- Product code
- MSL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-12
- Date received
- 1997-02-11
- Regulation
- 862.3350
- Classification name
- System, Test, Topiramatee
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNDA M TAYLOR
- Address
- 6040 N. Cutter Cir., #317 Portland OR US 97217 97217
Source Documents#
Legacy Summary#
summary
FDA Review#
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