510(k) K841360

MINOR SURGICAL LIGHT MODEL 180 by American Sterilizer Co. — Product Code FTD

K841360 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "MINOR SURGICAL LIGHT MODEL 180". The FDA issued a decision of Substantially Equivalent on April 24, 1984. The device falls under product code FTD (Lamp, Surgical), 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
April 24, 1984
Date Received
April 2, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Surgical
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type