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 |