The following data is part of a premarket notification filed by Mission Pharmacal Co. with the FDA for Maxilube.
| Device ID | K943010 |
| 510k Number | K943010 |
| Device Name: | MAXILUBE |
| Classification | Lubricant, Patient |
| Applicant | MISSION PHARMACAL CO. P.O. BOX 1676 San Antonio, TX 78296 |
| Contact | George Alexandrides |
| Correspondent | George Alexandrides MISSION PHARMACAL CO. P.O. BOX 1676 San Antonio, TX 78296 |
| Product Code | KMJ |
| CFR Regulation Number | 880.6375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-24 |
| Decision Date | 1995-07-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAXILUBE 78473513 3008832 Live/Registered |
Crawford, Stephen R 2004-08-25 |
![]() MAXILUBE 74602759 2077859 Dead/Cancelled |
MacNaught Pty. Limited 1994-11-23 |
![]() MAXILUBE 73143475 1090683 Live/Registered |
MISSION PHARMACAL COMPANY 1977-10-03 |