510(k) K962179

STAT IM 5000 CASSETTE AUTOCLAVE by Scican — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1997
Date Received
June 6, 1996
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