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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name sterilizer, steam
510(k) Number K990189
Device Name MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER
Applicant
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Applicant Contact JAMES RILE
Correspondent
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Correspondent Contact JAMES RILE
Regulation Number880.6880
Classification Product Code
FLE  
Date Received01/20/1999
Decision Date 04/19/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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