The following data is part of a premarket notification filed by Genteel, Llc with the FDA for Genteel Lancing Device.
| Device ID | K153670 |
| 510k Number | K153670 |
| Device Name: | Genteel Lancing Device |
| Classification | Lancet, Blood |
| Applicant | Genteel, LLC 4011 Livingstone St. Midland, TX 79707 |
| Contact | Christopher Jacobs |
| Correspondent | Mark Duval Duval & Associates, P.A. 825 Nicollet Mall, Suite 1820 Minneapolis, MN 55402 |
| Product Code | FMK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15907996098771 | K153670 | 000 |