510(k) K860020

MINOR SURGERY LIGHT MODEL 2112 by Adel Medical , Ltd. — Product Code FSS

K860020 is an FDA 510(k) premarket notification submitted by Adel Medical , Ltd. for the device "MINOR SURGERY LIGHT MODEL 2112". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Adel Medical , Ltd. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1986
Date Received
January 3, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Surgical, Floor Standing
Device Class
Class II
Regulation Number
878.4580
Review Panel
SU
Submission Type