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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 K911322
Device Name MODEL #M9 ULTRACLAVE STEAM STERILIZER
Applicant
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Applicant Contact JOHN OLDIGES
Correspondent
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Correspondent Contact JOHN OLDIGES
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/26/1991
Decision Date 08/26/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
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