510(k) K972026

SP4044 & SP4055 LUX MODULES by Satelec — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1997
Date Received
June 2, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type