The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Cbm, Core Build-up Material.
Device ID | K823732 |
510k Number | K823732 |
Device Name: | CBM, CORE BUILD-UP MATERIAL |
Classification | Coating, Filling Material, Resin |
Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-12-10 |
Decision Date | 1982-12-28 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
D801SP55191 | K823732 | 000 |
D801SP50095B1 | K823732 | 000 |
D801SP500951 | K823732 | 000 |
D801SP50094B1 | K823732 | 000 |
D801SP500941 | K823732 | 000 |
D801SP50093B1 | K823732 | 000 |
D801SP500931 | K823732 | 000 |
D801SP50092B1 | K823732 | 000 |
D801SP500921 | K823732 | 000 |
D801SP50091B1 | K823732 | 000 |
D801SP500911 | K823732 | 000 |
D801SP500961 | K823732 | 000 |
D801SP50096B1 | K823732 | 000 |
D801SP50191 | K823732 | 000 |
D801SP5509S1 | K823732 | 000 |
D801SP550941 | K823732 | 000 |
D801SP550921 | K823732 | 000 |
D801SP550911 | K823732 | 000 |
D801SP55091 | K823732 | 000 |
D801SP52091N1 | K823732 | 000 |
D801SP52091 | K823732 | 000 |
D801SP50391 | K823732 | 000 |
D801SP50291 | K823732 | 000 |
D801SP50193N1 | K823732 | 000 |
D801SP50091 | K823732 | 000 |