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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 K992744
Device Name MIDMARK M4*9 EASYCLAVE STEAM STERILIZER
Applicant
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Applicant Contact MIKE SNYDER
Correspondent
MIDMARK CORP.
60 VISTA DR.
P.O. BOX 286
VERSAILLES,  OH  45380
Correspondent Contact MIKE SNYDER
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/16/1999
Decision Date 01/10/2000
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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