510(k) K881331
K881331 is an FDA 510(k) premarket notification submitted by Flexmedics for the device "ORTHODONTIC NITINOL SPRINGS". The FDA issued a decision of Substantially Equivalent on April 21, 1988. The device falls under product code EJW (Clasp, Wire), a Class I device regulated under 21 CFR 872.3285. Flexmedics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 1988
- Date Received
- March 29, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clasp, Wire
- Device Class
- Class I
- Regulation Number
- 872.3285
- Review Panel
- DE
- Submission Type