510(k) K032757

A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE by A-Dec, Inc. — Product Code EIA

K032757 is an FDA 510(k) premarket notification submitted by A-Dec, Inc. for the device "A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE". The FDA issued a decision of Substantially Equivalent on December 10, 2003. The device falls under product code EIA (Unit, Operative Dental), a Class I device regulated under 21 CFR 872.6640. A-Dec, Inc. has at least 10 other 510(k) clearances on record.