The following data is part of a premarket notification filed by Pharmascience, Inc. with the FDA for Duraflor.
| Device ID | K961893 |
| 510k Number | K961893 |
| Device Name: | DURAFLOR |
| Classification | Varnish, Cavity |
| Applicant | PHARMASCIENCE, INC. 8235 ROANOKE CT. Severn, MD 21144 |
| Contact | Louis Hlavinka |
| Correspondent | Louis Hlavinka PHARMASCIENCE, INC. 8235 ROANOKE CT. Severn, MD 21144 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-16 |
| Decision Date | 1996-08-14 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DURAFLOR 76469017 not registered Dead/Abandoned |
Janitex Rug Service Corporation 2002-11-21 |
![]() DURAFLOR 73799834 1572861 Live/Registered |
PHARMASCIENCE INC. 1989-05-15 |