The following data is part of a premarket notification filed by Puricore, Inc. with the FDA for Sterilox Liquid Chemical Sterilant System.
| Device ID | K063159 |
| 510k Number | K063159 |
| Device Name: | STERILOX LIQUID CHEMICAL STERILANT SYSTEM |
| Classification | Sterilant, Medical Devices |
| Applicant | PURICORE, INC. 320 KING OF PRUSSIA ROAD SUITE 200 Radnor, PA 19087 |
| Contact | Howard Mann |
| Correspondent | Howard Mann PURICORE, INC. 320 KING OF PRUSSIA ROAD SUITE 200 Radnor, PA 19087 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-17 |
| Decision Date | 2007-04-02 |
| Summary: | summary |