510(k) K781581

SURGICAL LIGHT 22 SERIES by American Sterilizer Co. — Product Code FQP

K781581 is an FDA 510(k) premarket notification submitted by American Sterilizer Co. for the device "SURGICAL LIGHT 22 SERIES". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code FQP (Lamp, Operating-Room), 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
October 17, 1978
Date Received
September 15, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lamp, Operating-Room
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type