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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 K880090
Device Name ION TRAP DETECTOR
Applicant
Finnigan Corp.
355 River Oaks Pkwy.
San Jose,  CA  95134 -1991
Applicant Contact RICHARD L MAYEUR
Correspondent
Finnigan Corp.
355 River Oaks Pkwy.
San Jose,  CA  95134 -1991
Correspondent Contact RICHARD L MAYEUR
Regulation Number862.2860
Classification Product Code
DOP  
Date Received01/12/1988
Decision Date 03/15/1988
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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