510(k) K820104
K820104 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "NUPRO* GEL TRAY". The FDA issued a decision of Substantially Equivalent on February 23, 1982. The device falls under product code KMT (Tray, Fluoride, Disposable), a Class I device regulated under 21 CFR 872.6870. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 23, 1982
- Date Received
- January 15, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Fluoride, Disposable
- Device Class
- Class I
- Regulation Number
- 872.6870
- Review Panel
- DE
- Submission Type