The following data is part of a premarket notification filed by Int'l Corp. with the FDA for Hemo-nate L-p Kit.
| Device ID | K821814 |
| 510k Number | K821814 |
| Device Name: | HEMO-NATE L-P KIT |
| Classification | Kit, Surgical Instrument, Disposable |
| Applicant | INT'L CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KDD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-18 |
| Decision Date | 1982-07-09 |