510(k) K983679

STATIM 5000 CASSETTE AUTOCLAVE by Scican — Product Code FLE

K983679 is an FDA 510(k) premarket notification submitted by Scican for the device "STATIM 5000 CASSETTE AUTOCLAVE". The FDA issued a decision of Substantially Equivalent on January 4, 1999. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. Scican has at least 10 other 510(k) clearances on record.