The following data is part of a premarket notification filed by Sorensen Research with the FDA for Sorenson Catalog #ifl-120s.
| Device ID | K811228 |
| 510k Number | K811228 |
| Device Name: | SORENSON CATALOG #IFL-120S |
| Classification | Apparatus, Autotransfusion |
| Applicant | SORENSEN RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-05-04 |
| Decision Date | 1981-06-09 |