The following data is part of a premarket notification filed by Jensen Int'l, Inc. with the FDA for Willi Geller Creation Ii Porcelain.
| Device ID | K043468 |
| 510k Number | K043468 |
| Device Name: | WILLI GELLER CREATION II PORCELAIN |
| Classification | Powder, Porcelain |
| Applicant | JENSEN INT'L, INC. 50 STILLMAN ROAD North Haven, CT 06473 |
| Contact | Gary Phelps |
| Correspondent | Gary Phelps JENSEN INT'L, INC. 50 STILLMAN ROAD North Haven, CT 06473 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-16 |
| Decision Date | 2005-01-12 |
| Summary: | summary |