The following data is part of a premarket notification filed by Common Sense, Ltd. with the FDA for Vs-sense Test.
| Device ID | K091287 |
| 510k Number | K091287 |
| Device Name: | VS-SENSE TEST |
| Classification | Dye-indicator, Ph (urinary, Non-quantitative) |
| Applicant | COMMON SENSE, LTD. 777 6TH STREET NW SUITE 1100 Washington, DC 20001 |
| Contact | Natasha Leskovsek |
| Correspondent | Natasha Leskovsek COMMON SENSE, LTD. 777 6TH STREET NW SUITE 1100 Washington, DC 20001 |
| Product Code | CEN |
| CFR Regulation Number | 862.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-01 |
| Decision Date | 2009-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290006558183 | K091287 | 000 |
| 07290006558176 | K091287 | 000 |
| 07290006558169 | K091287 | 000 |