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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cleaner, Ultrasonic, Medical Instrument
510(k) Number K771679
Device Name MICROFLATOR
Applicant
Fisons Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Fisons Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6150
Classification Product Code
FLG  
Date Received09/06/1977
Decision Date 09/28/1977
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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