The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide Sensual Strawberry Personal Lubricant.
Device ID | K213671 |
510k Number | K213671 |
Device Name: | Astroglide Sensual Strawberry Personal Lubricant |
Classification | Lubricant, Personal |
Applicant | BioFilm Inc. 3225 Executive Ridge Vista, CA 92081 |
Contact | Jennifer Keller |
Correspondent | Jennifer Keller BioFilm Inc. 3225 Executive Ridge Vista, CA 92081 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-11-22 |
Decision Date | 2022-03-03 |