The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Eugenone.
Device ID | K051952 |
510k Number | K051952 |
Device Name: | EUGENONE |
Classification | Cement, Dental |
Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
Contact | Jan A Orlowski |
Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-18 |
Decision Date | 2005-09-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850015110078 | K051952 | 000 |
D801SP515011 | K051952 | 000 |
D801SP51501 | K051952 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EUGENONE 77374681 3488213 Live/Registered |
SCIENTIFIC PHARMACEUTICALS, INC. 2008-01-17 |