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 |