510(k) K896674
K896674 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "AMSCO QUANTUM LIGHT". The FDA issued a decision of Substantially Equivalent on January 3, 1990. The device falls under product code FSY (Light, Surgical, Ceiling Mounted), a Class II device regulated under 21 CFR 878.4580. American Sterilizer Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1990
- Date Received
- November 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light, Surgical, Ceiling Mounted
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type