The following data is part of a premarket notification filed by Imquest Biosciences Inc. with the FDA for Flip Lube.
| Device ID | K171516 |
| 510k Number | K171516 |
| Device Name: | Flip Lube |
| Classification | Lubricant, Personal |
| Applicant | Imquest Biosciences Inc. 7340 Executive Way, Suite R Frederick, MD 21704 |
| Contact | Karen W. Buckheit |
| Correspondent | Paul Dryden ImQuest Biosciences, Inc. C/o ProMedical LLC 24301 Woodsage Dr. Bonita Springs, FL 34134 -2958 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-24 |
| Decision Date | 2018-02-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853517007020 | K171516 | 000 |
| 00853517007013 | K171516 | 000 |