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 |