The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Oxide Anaerobic System.
Device ID | K800430 |
510k Number | K800430 |
Device Name: | OXIDE ANAEROBIC SYSTEM |
Classification | Anaerobic Box Glove |
Applicant | OXOID U.S.A., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JTM |
CFR Regulation Number | 866.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-26 |
Decision Date | 1980-04-02 |