510(k) K812120
K812120 is an FDA 510(k) premarket notification submitted by Belport Co., Inc. for the device "GINGI-PLAIN CORDS & BRAIDS". The FDA issued a decision of Substantially Equivalent on Sep 8, 1981. The device falls under product code JES (Floss, Dental), a Class I device regulated under 21 CFR 872.6390. Belport Co., Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 8, 1981
- Date Received
- Jul 27, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Floss, Dental
- Device Class
- Class I
- Regulation Number
- 872.6390
- Review Panel
- DE
- Submission Type
- 510(k) Exempt