The following data is part of a premarket notification filed by Biofilm Inc. with the FDA for Astroglide O Oil Personal Lubricant & Massage Oil.
| Device ID | K171985 |
| 510k Number | K171985 |
| Device Name: | Astroglide O Oil Personal Lubricant & Massage Oil |
| 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 | 2017-07-03 |
| Decision Date | 2017-08-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594011417 | K171985 | 000 |
| 00015594011738 | K171985 | 000 |
| 00015594011844 | K171985 | 000 |