510(k) K032267
K032267 is an FDA 510(k) premarket notification submitted by Jensen Industries, Inc. for the device "R&D DESIGNATION AP-052-5". The FDA issued a decision of Substantially Equivalent on Sep 17, 2003. 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
- Sep 17, 2003
- Date Received
- Jul 23, 2003
- 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