The following data is part of a premarket notification filed by 3m Company with the FDA for Steri-vac #400c Gas Sterilizer.
Device ID | K812867 |
510k Number | K812867 |
Device Name: | STERI-VAC #400C GAS STERILIZER |
Classification | Sterilizer, Ethylene-oxide Gas |
Applicant | 3M COMPANY 2724 SOUTH PECK RD. Monrovia, CA 91016 |
Product Code | FLF |
CFR Regulation Number | 880.6860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-10-13 |
Decision Date | 1981-11-02 |