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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrumentation, High Pressure Liquid Chromatography
510(k) Number K884886
Device Name MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
Applicant
The Perkin-Elmer Corp.
761 Main Ave.
Norwalk,  CT  06859
Applicant Contact RAYMOND M TRENCK
Correspondent
The Perkin-Elmer Corp.
761 Main Ave.
Norwalk,  CT  06859
Correspondent Contact RAYMOND M TRENCK
Regulation Number862.2260
Classification Product Code
LDM  
Date Received11/22/1988
Decision Date 02/02/1989
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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