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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test Reagents For Phenothiazine
510(k) Number K894657
Device Name POLYSTAN HEART-LUNG MACHINE SYSTEM
Applicant
Polystan C/O Vitalcor, Inc.
8, Walgerholm
Dk-3500 Vaerlose
Denmark,  DK
Applicant Contact HENNING LARSEN
Correspondent
Polystan C/O Vitalcor, Inc.
8, Walgerholm
Dk-3500 Vaerlose
Denmark,  DK
Correspondent Contact HENNING LARSEN
Regulation Number862.3670
Classification Product Code
DJQ  
Date Received07/24/1989
Decision Date 03/28/1990
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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