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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Pipette, Quantitative, Hematology
510(k) Number K831079
Device Name LIQUIPETTE
Applicant
The Kendall Company Div. of Tyco Healthcare Group
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Kendall Company Div. of Tyco Healthcare Group
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.6160
Classification Product Code
GJG  
Date Received04/04/1983
Decision Date 04/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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