510(k) K022206
K022206 is an FDA 510(k) premarket notification submitted by Jensen Industries, Inc. for the device "JENSEN GOLD FOIL". The FDA issued a decision of Substantially Equivalent on Aug 29, 2002. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Jensen Industries, Inc. has 16 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 2002
- Date Received
- Jul 5, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Alloy, Gold-Based Noble Metal
- Device Class
- Class II
- Regulation Number
- 872.3060
- Review Panel
- DE
- Submission Type
- 510(k) Exempt