The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Calcium Procedure.
Device ID | K832183 |
510k Number | K832183 |
Device Name: | SANDARE CALCIUM PROCEDURE |
Classification | Cresolphthalein Complexone, Calcium |
Applicant | SANDARE CHEMICAL CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | CIC |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-07-06 |
Decision Date | 1983-08-24 |