The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for R&d Designation Ap-052-5.
| Device ID | K032267 |
| 510k Number | K032267 |
| Device Name: | R&D DESIGNATION AP-052-5 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
| Contact | John Slanski |
| Correspondent | John Slanski JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-23 |
| Decision Date | 2003-09-17 |
| Summary: | summary |