The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for Willi Geller Creation Cp Porcelain.
| Device ID | K043221 |
| 510k Number | K043221 |
| Device Name: | WILLI GELLER CREATION CP PORCELAIN |
| Classification | Powder, Porcelain |
| Applicant | JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
| Contact | Gary Phelps |
| Correspondent | Gary Phelps JENSEN INDUSTRIES, INC. 50 STILLMAN RD. North Haven, CT 06473 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-22 |
| Decision Date | 2004-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| ECWG7005511 | K043221 | 000 |
| ECWG7005411 | K043221 | 000 |
| ECWG7005271 | K043221 | 000 |