The following data is part of a premarket notification filed by Oxis Intl., Inc. with the FDA for Innofluor Topiramate Control Set.
Device ID | K970517 |
510k Number | K970517 |
Device Name: | INNOFLUOR TOPIRAMATE CONTROL SET |
Classification | Drug Specific Control Materials |
Applicant | OXIS INTL., INC. 6040 N. CUTTER CIRCLE, SUITE 317 Portland, OR 97217 -3935 |
Contact | Lynda M Taylor |
Correspondent | Lynda M Taylor OXIS INTL., INC. 6040 N. CUTTER CIRCLE, SUITE 317 Portland, OR 97217 -3935 |
Product Code | LAS |
CFR Regulation Number | 862.3280 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-02-11 |
Decision Date | 1997-05-12 |
Summary: | summary |