The following data is part of a premarket notification filed by Medical House Products Limited with the FDA for Cool.click 2.
| Device ID | K060819 |
| 510k Number | K060819 |
| Device Name: | COOL.CLICK 2 |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | MEDICAL HOUSE PRODUCTS LIMITED 199 NEWHALL ROAD Sheffield, GB S9 2qj |
| Contact | Rose Y Guang |
| Correspondent | Rose Y Guang MEDICAL HOUSE PRODUCTS LIMITED 199 NEWHALL ROAD Sheffield, GB S9 2qj |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-27 |
| Decision Date | 2006-06-16 |
| Summary: | summary |