510(k) K990189

MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER by Midmark Corp. — Product Code FLE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1999
Date Received
January 20, 1999
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