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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 K844649
Device Name ELECTRICALLY HEATED STERILIZER STEAM STERILIZER
Applicant
Takizawa Medical Instruments Manufacturer
570 Lexington Ave.
New York,  NY  10022
Applicant Contact HIDEO MARUKI
Correspondent
Takizawa Medical Instruments Manufacturer
570 Lexington Ave.
New York,  NY  10022
Correspondent Contact HIDEO MARUKI
Regulation Number880.6880
Classification Product Code
FLE  
Date Received11/29/1984
Decision Date 08/05/1985
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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