510(k) K943068
K943068 is an FDA 510(k) premarket notification submitted by Ormco Corp. for the device "MAGNEFORCE". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code ECO (Spring, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Ormco Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1994
- Date Received
- June 28, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spring, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5410
- Review Panel
- DE
- Submission Type