The following data is part of a premarket notification filed by Pall Biomedical Products Co. with the FDA for Solution Clarification Unit.
| Device ID | K842141 |
| 510k Number | K842141 |
| Device Name: | SOLUTION CLARIFICATION UNIT |
| Classification | Filter, Prebypass, Cardiopulmonary Bypass |
| Applicant | PALL BIOMEDICAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRJ |
| CFR Regulation Number | 870.4280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-08-03 |