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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K913567
Device Name WELLPREP 1
Applicant
Denley Instruments, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Applicant Contact CHRIS PANNUNZIO
Correspondent
Denley Instruments, Inc.
3 Bethesda Metro Center
Suite 750
Bethesda,  MD  20814
Correspondent Contact CHRIS PANNUNZIO
Regulation Number862.2750
Classification Product Code
JQW  
Date Received08/09/1991
Decision Date 10/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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