510(k) K761341
K761341 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "PORTAGAS AERATOR". The FDA issued a decision of Substantially Equivalent on February 28, 1977. The device falls under product code FLI (Cabinet, Ethylene-Oxide Gas Aerator), a Class II device regulated under 21 CFR 880.6100. Amsco Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1977
- Date Received
- December 28, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, Ethylene-Oxide Gas Aerator
- Device Class
- Class II
- Regulation Number
- 880.6100
- Review Panel
- HO
- Submission Type