The following data is part of a premarket notification filed by Trigg Laboratories, Inc. with the FDA for Wet Essential95 Personal Lubricant.
Device ID | K220534 |
510k Number | K220534 |
Device Name: | Wet Essential95 Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | Trigg Laboratories, Inc. 4220 W. Windmill Ln. Suite 140 Las Vegas, NV 89139 |
Contact | Marla Bolden |
Correspondent | Marla Bolden Trigg Laboratories, Inc. 4220 W. Windmill Ln. Suite 140 Las Vegas, NV 89139 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-02-24 |
Decision Date | 2022-07-07 |