510(k) K032995
K032995 is an FDA 510(k) premarket notification submitted by Micron Corp. for the device "SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL)". The FDA issued a decision of Substantially Equivalent on Nov 20, 2003. 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
- Nov 20, 2003
- Date Received
- Sep 25, 2003
- Clearance Type
- Special
- 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)