510(k) K983679

STATIM 5000 CASSETTE AUTOCLAVE by Scican — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1999
Date Received
October 20, 1998
Clearance Type
Special
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