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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mass Spectrometer, Clinical Use
510(k) Number K880418
Device Name INCOS 50 MASS SPECTROMETER
Applicant
Finnigan Corp.
7 Regent St.
Suite 711
Livingston,  NJ  07039
Applicant Contact LEHRER, PHD
Correspondent
Finnigan Corp.
7 Regent St.
Suite 711
Livingston,  NJ  07039
Correspondent Contact LEHRER, PHD
Regulation Number862.2860
Classification Product Code
DOP  
Date Received02/01/1988
Decision Date 05/31/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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