The following data is part of a premarket notification filed by Jensen Industries, Inc. with the FDA for Jensen Shade Effect Liquids.
| Device ID | K183408 |
| 510k Number | K183408 |
| Device Name: | Jensen Shade Effect Liquids |
| Classification | Powder, Porcelain |
| Applicant | Jensen Industries, Inc. 50 Stillman Road North Haven, CT 06473 |
| Contact | Jordan Schreck |
| Correspondent | Jordan Schreck Jensen Industries, 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 | 2018-12-10 |
| Decision Date | 2019-03-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817340025118 | K183408 | 000 |
| 00817340025125 | K183408 | 000 |
| 00817340025101 | K183408 | 000 |
| 00817340025767 | K183408 | 000 |