The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide X Silicone Personal Lubricant.
| Device ID | K210242 |
| 510k Number | K210242 |
| Device Name: | Astroglide X Silicone Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | BioFilm Inc. 3225 Executive Ridge Vista, CA 92081 |
| Contact | Kevin Jamil |
| Correspondent | Kevin Jamil 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 | 2021-01-29 |
| Decision Date | 2021-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594011837 | K210242 | 000 |
| 00015594012094 | K210242 | 000 |