510(k) K842208
K842208 is an FDA 510(k) premarket notification submitted by Parexel Intl. Corp. for the device "NATURA-TONE OR LUXOPAL CL ACRYLIC". The FDA issued a decision of Substantially Equivalent on July 31, 1984. The device falls under product code ELM (Denture, Plastic, Teeth), a Class II device regulated under 21 CFR 872.3590. Parexel Intl. Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1984
- Date Received
- June 4, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Denture, Plastic, Teeth
- Device Class
- Class II
- Regulation Number
- 872.3590
- Review Panel
- DE
- Submission Type