The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Glycerin & Paraben Free Astroglide.
| Device ID | K072647 |
| 510k Number | K072647 |
| Device Name: | GLYCERIN & PARABEN FREE ASTROGLIDE |
| Classification | Lubricant, Personal |
| Applicant | BIOFILM, INC. 3225 EXECUTIVE RIDGE Vista, CA 92081 |
| Contact | Robert De Armond |
| Correspondent | Robert De Armond 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 | 2007-09-19 |
| Decision Date | 2008-01-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594011882 | K072647 | 000 |
| 00015594010632 | K072647 | 000 |
| 00015594011929 | K072647 | 000 |
| 00015594011776 | K072647 | 000 |