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 |