The following data is part of a premarket notification filed by Medivators, Inc. with the FDA for Medivators 5 Minute High-level Disinfectant.
| Device ID | K993042 |
| 510k Number | K993042 |
| Device Name: | MEDIVATORS 5 MINUTE HIGH-LEVEL DISINFECTANT |
| Classification | Sterilant, Medical Devices |
| Applicant | MEDIVATORS, INC. 7423 AIRPORT FREEWAY Fort Worth, TX 76118 |
| Contact | Norman Miner |
| Correspondent | Norman Miner MEDIVATORS, INC. 7423 AIRPORT FREEWAY Fort Worth, TX 76118 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-10 |
| Decision Date | 2000-08-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30677964034856 | K993042 | 000 |