SANDARE CALCIUM PROCEDURE

Cresolphthalein Complexone, Calcium

SANDARE CHEMICAL CO., INC.

The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Calcium Procedure.

Pre-market Notification Details

Device IDK832183
510k NumberK832183
Device Name:SANDARE CALCIUM PROCEDURE
ClassificationCresolphthalein Complexone, Calcium
Applicant SANDARE CHEMICAL CO., INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-06
Decision Date1983-08-24

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