510(k) K902036

STERI-VAC GAS STERILIZER MODEL 5XL by 3M Company — Product Code FLF

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