The following data is part of a premarket notification filed by Bio-tech Lubricants Ltd with the FDA for Ah!yes Ob Coco Personal Lubricant.
| Device ID | K191411 |
| 510k Number | K191411 |
| Device Name: | Ah!Yes Ob Coco Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | Bio-Tech Lubricants Ltd C/O Epsilon House, Enterprise Road, Southampton Science Park Southampton, GB So16 7ns |
| Contact | Sarah Brooks |
| Correspondent | Karen Cornelius Bio-Tech Lubricants Ltd C/O The Timber Barn, Selborne Road Greatham, Liss, GB Gu33 6hg |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-28 |
| Decision Date | 2020-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060104171506 | K191411 | 000 |
| 05060104171490 | K191411 | 000 |