The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Astroglide Natural.
| Device ID | K141581 |
| 510k Number | K141581 |
| Device Name: | ASTROGLIDE NATURAL |
| Classification | Lubricant, Personal |
| Applicant | BIOFILM, INC. 3225 Executive Rdg Vista, CA 92081 |
| Contact | Sherry Castello |
| Correspondent | Sherry Castello BIOFILM, INC. 3225 Executive Rdg 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 | 2014-06-13 |
| Decision Date | 2014-08-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594010946 | K141581 | 000 |