510(k) K872622
K872622 is an FDA 510(k) premarket notification submitted by Wonder Wire for the device "ORTHODONTIC ARCH". The FDA issued a decision of Substantially Equivalent on Oct 9, 1987. The device falls under product code EJZ (Knife, Margin Finishing, Operative), a Class I device regulated under 21 CFR 872.4565. Wonder Wire has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 9, 1987
- Date Received
- Jul 6, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Knife, Margin Finishing, Operative
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type
- 510(k) Exempt