510(k) K780814
K780814 is an FDA 510(k) premarket notification submitted by Northwest Orthodontics, Inc. for the device "SAFETY STOP NECKSTRAP". The FDA issued a decision of Substantially Equivalent on June 30, 1978. The device falls under product code DYT (Maintainer, Space Preformed, Orthodontic), a Class I device regulated under 21 CFR 872.5525. Northwest Orthodontics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 1978
- Date Received
- May 18, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Maintainer, Space Preformed, Orthodontic
- Device Class
- Class I
- Regulation Number
- 872.5525
- Review Panel
- DE
- Submission Type