The following data is part of a premarket notification filed by Astral Medical Systems with the FDA for Modified Coatron Ii And Coatron Jr..
| Device ID | K900506 |
| 510k Number | K900506 |
| Device Name: | MODIFIED COATRON II AND COATRON JR. |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | ASTRAL MEDICAL SYSTEMS 6911 HILLSDALE COURT Indianapolis, IN 46250 |
| Contact | Gary D Sears |
| Correspondent | Gary D Sears ASTRAL MEDICAL SYSTEMS 6911 HILLSDALE COURT Indianapolis, IN 46250 |
| Product Code | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-02 |
| Decision Date | 1990-03-12 |