The following data is part of a premarket notification filed by Trigg Laboratories D/b/a Wet International with the FDA for Wet Original Personal Lubricant.
| Device ID | K160211 |
| 510k Number | K160211 |
| Device Name: | Wet Original Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | TRIGG LABORATORIES D/B/A WET INTERNATIONAL 28650 BRAXTON AVENUE Valencia, CA 91355 |
| Contact | Erica Loring |
| Correspondent | Erica Loring TRIGG LABORATORIES D/B/A WET INTERNATIONAL 28650 BRAXTON AVENUE Valencia, CA 91355 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-28 |
| Decision Date | 2016-04-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00716222241007 | K160211 | 000 |