510(k) K991239

VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 by Micron Corp. — Product Code ELC

K991239 is an FDA 510(k) premarket notification submitted by Micron Corp. for the device "VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2". The FDA issued a decision of Substantially Equivalent on Oct 18, 1999. The device falls under product code ELC (Scaler, Ultrasonic), a Class II device regulated under 21 CFR 872.4850. Micron Corp. has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 18, 1999
Date Received
Apr 12, 1999
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
510(k)