CBM, CORE BUILD-UP MATERIAL

Coating, Filling Material, Resin

SCIENTIFIC PHARMACEUTICALS, INC.

The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Cbm, Core Build-up Material.

Pre-market Notification Details

Device IDK823732
510k NumberK823732
Device Name:CBM, CORE BUILD-UP MATERIAL
ClassificationCoating, Filling Material, Resin
Applicant SCIENTIFIC PHARMACEUTICALS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeEBD  
CFR Regulation Number872.3310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-10
Decision Date1982-12-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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