510(k) K991239
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)