The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Simplex Enhancement Mixer.
| Device ID | K853310 |
| 510k Number | K853310 |
| Device Name: | SIMPLEX ENHANCEMENT MIXER |
| Classification | Mixer, Cement, For Clinical Use |
| Applicant | HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Charles H Lawyer |
| Correspondent | Charles H Lawyer HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JDZ |
| CFR Regulation Number | 888.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-07 |
| Decision Date | 1985-09-11 |