510(k) K844234
K844234 is an FDA 510(k) premarket notification submitted by Active Vertical Correctors, Inc. for the device "ACTIVE VERTICAL CORRECTOR APPLIANCE". The FDA issued a decision of Substantially Equivalent on January 4, 1985. The device falls under product code ECO (Spring, Orthodontic), a Class I device regulated under 21 CFR 872.5410. Active Vertical Correctors, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1985
- Date Received
- November 1, 1984
- 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