The following data is part of a premarket notification filed by Biofilm, Inc. with the FDA for Good Lubrications.
| Device ID | K020586 |
| 510k Number | K020586 |
| Device Name: | GOOD LUBRICATIONS |
| Classification | Lubricant, Patient |
| 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 | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-02-22 |
| Decision Date | 2003-01-24 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() GOOD LUBRICATIONS 78238980 2828029 Dead/Cancelled |
OPEN ENTERPRISES, INC. 2003-04-17 |