510(k) K021064

QUANTIM 16 AUTOCLAVE by Scican — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2002
Date Received
April 2, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Steam
Device Class
Class II
Regulation Number
880.6880
Review Panel
HO
Submission Type