The following data is part of a premarket notification filed by Acumed Instruments Corp. with the FDA for Acu-med Red Miser Hemothorax Blood Coll..
| Device ID | K791891 |
| 510k Number | K791891 |
| Device Name: | ACU-MED RED MISER HEMOTHORAX BLOOD COLL. |
| Classification | Apparatus, Autotransfusion |
| Applicant | ACUMED INSTRUMENTS CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-25 |
| Decision Date | 1979-12-05 |