The following data is part of a premarket notification filed by Damon Corp. with the FDA for Spinette Centrifuge.
| Device ID | K761013 |
| 510k Number | K761013 |
| Device Name: | SPINETTE CENTRIFUGE |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | DAMON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-11-09 |
| Decision Date | 1976-11-16 |