The following data is part of a premarket notification filed by Discus Dental Inc. with the FDA for Dischem Chemical Proportioning & Dispensing System For Use With Cetylcide-g Concentrate And Diluent, Aquarius Model.
| Device ID | K033381 |
| 510k Number | K033381 |
| Device Name: | DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL |
| Classification | Sterilant, Medical Devices |
| Applicant | DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
| Contact | Steven L Ziemba |
| Correspondent | Steven L Ziemba DISCUS DENTAL INC. 8550 HIGUERA ST. Culver City, CA 90232 |
| Product Code | MED |
| CFR Regulation Number | 880.6885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-22 |
| Decision Date | 2004-01-27 |