510(k) K033381

DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL by Discus Dental, Inc. — Product Code MED

K033381 is an FDA 510(k) premarket notification submitted by Discus Dental, Inc. for the device "DISCHEM CHEMICAL PROPORTIONING & DISPENSING SYSTEM FOR USE WITH CETYLCIDE-G CONCENTRATE AND DILUENT, AQUARIUS MODEL". The FDA issued a decision of Substantially Equivalent on January 27, 2004. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Discus Dental, Inc. has at least 10 other 510(k) clearances on record.