510(k) K896674

AMSCO QUANTUM LIGHT by American Sterilizer Co. — Product Code FSY

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