The following data is part of a premarket notification filed by Dorea, Inc. with the FDA for Max It.
| Device ID | K983438 |
| 510k Number | K983438 |
| Device Name: | MAX IT |
| Classification | Device, External Penile Rigidity |
| Applicant | DOREA, INC. 19 4TH AVENUE, S.E. Cairo, GA 31728 |
| Contact | Richard V Moses,jr. |
| Correspondent | Richard V Moses,jr. DOREA, INC. 19 4TH AVENUE, S.E. Cairo, GA 31728 |
| Product Code | LKY |
| CFR Regulation Number | 876.5020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-29 |
| Decision Date | 1999-02-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MAX IT 85940557 not registered Dead/Abandoned |
L'Oreal 2013-05-23 |
![]() MAX IT 75222808 2180046 Dead/Cancelled |
MCDONALD'S CORPORATION 1997-01-08 |
![]() MAX IT 75200301 2114137 Dead/Cancelled |
INTIMO, INC. 1996-11-19 |
![]() MAX IT 74409141 not registered Dead/Abandoned |
Trends Clothing Corp. 1993-06-30 |