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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thin Layer Chromatography, Ethosuximide
510(k) Number K901531
Device Name PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE
Applicant
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Applicant Contact WRIGHT,PHD
Correspondent
Pioneering Technologies, Inc.
3900 Youngfield St.
Wheat Ridge,  CO  80033
Correspondent Contact WRIGHT,PHD
Regulation Number862.3380
Classification Product Code
DNP  
Date Received03/22/1990
Decision Date 06/20/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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