The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide Ultra Gentle Gel.
| Device ID | K220355 |
| 510k Number | K220355 |
| Device Name: | Astroglide Ultra Gentle Gel |
| 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 | 2022-02-08 |
| Decision Date | 2022-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594011035 | K220355 | 000 |
| 00015594011813 | K220355 | 000 |