The following data is part of a premarket notification filed by Common Sense, Ltd. with the FDA for Amniscreen Home Detection Liner Kit.
| Device ID | K071100 |
| 510k Number | K071100 |
| Device Name: | AMNISCREEN HOME DETECTION LINER KIT |
| Classification | Dye-indicator, Ph (urinary, Non-quantitative) |
| Applicant | COMMON SENSE, LTD. 1717 RHODE ISLAND AVE., NW Washington, DC 20036 -3001 |
| Contact | Natasha Leskovsek |
| Correspondent | Natasha Leskovsek COMMON SENSE, LTD. 1717 RHODE ISLAND AVE., NW Washington, DC 20036 -3001 |
| Product Code | CEN |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-19 |
| Decision Date | 2007-10-15 |
| Summary: | summary |