The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Boston Post Cement.
Device ID | K870334 |
510k Number | K870334 |
Device Name: | BOSTON POST CEMENT |
Classification | Cement, Dental |
Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
Contact | Jan A Orlowski |
Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-28 |
Decision Date | 1987-02-19 |