510(k) K915054

STATIM CASSETT AUTOCLAVE, MODIFICATION by Scican — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1992
Date Received
November 4, 1991
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