Dischem Chemical Proportioning & Dispensing System for Use with Cetylcide-G Concentrate and Diluent, Aquarius Model
FDA 510(k) K033381 · Discus Dental, Inc.
510(k) numberK033381
Submission
- Device name
- Dischem Chemical Proportioning & Dispensing System for Use with Cetylcide-G Concentrate and Diluent, Aquarius Model
- Applicant
- Discus Dental, Inc.
Culver City, CA, US - Received
- October 22, 2003
- Decision date
- January 27, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
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Questions and answers
When was Dischem Chemical Proportioning & Dispensing System for Use with Cetylcide-G Concentrate and Diluent, Aquarius Model cleared by the FDA?
Dischem Chemical Proportioning & Dispensing System for Use with Cetylcide-G Concentrate and Diluent, Aquarius Model (K033381) received a 510(k) decision of Substantially Equivalent on January 27, 2004, 97 days after the submission was received.
What is the product code of K033381?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.