The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Matrix Ccm 600.
| Device ID | K926009 |
| 510k Number | K926009 |
| Device Name: | MATRIX CCM 600 |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | HERAEUS KULZER, INC. 1 RAMLAND RD. Orangeburg, NY 10962 |
| Contact | Mark G Kalafut |
| Correspondent | Mark G Kalafut HERAEUS KULZER, INC. 1 RAMLAND RD. Orangeburg, NY 10962 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-02 |
| Decision Date | 1993-07-20 |