The following data is part of a premarket notification filed by Data Medical Associates, Inc. with the FDA for Dma Calcium Plus Procedure.
Device ID | K944255 |
510k Number | K944255 |
Device Name: | DMA CALCIUM PLUS PROCEDURE |
Classification | Azo Dye, Calcium |
Applicant | DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Contact | C H Morris |
Correspondent | C H Morris DATA MEDICAL ASSOCIATES, INC. 845 AVENUE G EAST Arlington, TX 76011 |
Product Code | CJY |
CFR Regulation Number | 862.1145 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-01 |
Decision Date | 1994-12-06 |