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 |