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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 K872464
Device Name ION TRAP DETECTOR (ITD)
Applicant
The Perkin-Elmer Corp.
CT  06856
Applicant Contact RAYMOND M TRENCK
Correspondent
The Perkin-Elmer Corp.
CT  06856
Correspondent Contact RAYMOND M TRENCK
Regulation Number862.2860
Classification Product Code
DOP  
Date Received06/23/1987
Decision Date 08/11/1987
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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