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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Cleaner, Automated, Endoscope
510(k) Number K871712
Device Name MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT.
Applicant
Machida America, Inc.
40 Ramland Rd.
Orangeburg,  NY  10962
Applicant Contact RON PELL
Correspondent
Machida America, Inc.
40 Ramland Rd.
Orangeburg,  NY  10962
Correspondent Contact RON PELL
Regulation Number876.1500
Classification Product Code
NVE  
Date Received05/04/1987
Decision Date 01/14/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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