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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Evacuator, Gastro-Urology
510(k) Number K910728
Device Name CLEANFLOW SYSTEM
Applicant
Mitron Technologies, Inc.
514 Hartford Tpke.
P.O. Box 776
Dayville,  CT  06241
Applicant Contact GENE ZAMBA
Correspondent
Mitron Technologies, Inc.
514 Hartford Tpke.
P.O. Box 776
Dayville,  CT  06241
Correspondent Contact GENE ZAMBA
Regulation Number876.4370
Classification Product Code
KQT  
Date Received02/20/1991
Decision Date 04/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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