The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Mixing Bowl & Spatula, Disposable.
| Device ID | K780857 |
| 510k Number | K780857 |
| Device Name: | MIXING BOWL & SPATULA, DISPOSABLE |
| Classification | Mixer, Cement, For Clinical Use |
| Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDZ |
| CFR Regulation Number | 888.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-05-24 |
| Decision Date | 1978-06-13 |