The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide Diamond Silicone Gel Personal Lubricant.
| Device ID | K163395 |
| 510k Number | K163395 |
| Device Name: | Astroglide Diamond Silicone Gel Personal Lubricant |
| Classification | Lubricant, Personal |
| Applicant | BioFilm, Inc. 3225 Executive Ridge Vista, CA 92081 |
| Contact | Richard Hines |
| Correspondent | Richard Hines 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 | 2016-12-05 |
| Decision Date | 2017-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594011202 | K163395 | 000 |
| 00015594011752 | K163395 | 000 |
| 00015594011769 | K163395 | 000 |