510(k) K902036
K902036 is an FDA 510(k) premarket notification submitted by 3M Company for the device "STERI-VAC GAS STERILIZER MODEL 5XL". The FDA issued a decision of Substantially Equivalent on July 19, 1990. The device falls under product code FLF (Sterilizer, Ethylene-Oxide Gas), a Class II device regulated under 21 CFR 880.6860. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1990
- Date Received
- May 3, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Ethylene-Oxide Gas
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type