The following data is part of a premarket notification filed by Mdt Biologic Co. with the FDA for Harvey Chemiclave Ec5000, Ec5500, Ec6000 Sterilizers.
| Device ID | K943654 |
| 510k Number | K943654 |
| Device Name: | HARVEY CHEMICLAVE EC5000, EC5500, EC6000 STERILIZERS |
| Classification | Sterilizer, Chemical |
| Applicant | MDT BIOLOGIC CO. 19645 RANCHO WAY Rancho Dominguez, CA 90220 |
| Contact | Mark N Smith, P.e. |
| Correspondent | Mark N Smith, P.e. MDT BIOLOGIC CO. 19645 RANCHO WAY Rancho Dominguez, CA 90220 |
| Product Code | MLR |
| CFR Regulation Number | 880.6860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1995-08-02 |