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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 K951273
Device Name BUXTON BUILT STERILIZER, BUXTON BUILT RECONDITIONED STERILIZER
Applicant
Buxton Medical Servic Corp.
67 Mill St.
Amityville,  NY  11701
Applicant Contact CARL B NEWMAN
Correspondent
Buxton Medical Servic Corp.
67 Mill St.
Amityville,  NY  11701
Correspondent Contact CARL B NEWMAN
Regulation Number880.6880
Classification Product Code
FLE  
Date Received03/21/1995
Decision Date 08/08/1995
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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