The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide Brand Warming Liquid Personal Lubricant.
| Device ID | K041432 |
| 510k Number | K041432 |
| Device Name: | ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT |
| Classification | Condom |
| Applicant | BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista, CA 92081 |
| Contact | Robert L De Armond |
| Correspondent | Robert L De Armond BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista, CA 92081 |
| Product Code | HIS |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-28 |
| Decision Date | 2004-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594010342 | K041432 | 000 |
| 00015594011967 | K041432 | 000 |