The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Exam Room Astroglide (professional Market), Target Lubricating Jelly (otc Consumer Market).
| Device ID | K003867 |
| 510k Number | K003867 |
| Device Name: | EXAM ROOM ASTROGLIDE (PROFESSIONAL MARKET), TARGET LUBRICATING JELLY (OTC CONSUMER MARKET) |
| Classification | Lubricant, Personal |
| Applicant | BIOFILM, INC. 3121 SCOTT ST. Vista, CA 92083 |
| Contact | Robert L De Armond |
| Correspondent | Robert L De Armond BIOFILM, INC. 3121 SCOTT ST. Vista, CA 92083 |
| Product Code | NUC |
| CFR Regulation Number | 884.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-12 |
| Decision Date | 2001-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00015594010106 | K003867 | 000 |
| 00015594011851 | K003867 | 000 |