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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 K895275
Device Name MAC LAVE STEAM STERILIZER
Applicant
Merchants Export Development Corp.
One Merchants Plz., Suite
770 S.
Indianapolis,  IN  46255
Applicant Contact DAVID P BENNETT
Correspondent
Merchants Export Development Corp.
One Merchants Plz., Suite
770 S.
Indianapolis,  IN  46255
Correspondent Contact DAVID P BENNETT
Regulation Number880.6880
Classification Product Code
FLE  
Date Received08/23/1989
Decision Date 11/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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