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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K842215
Device Name ASCORBIC ACID
Applicant
ORGANON TEKNIKA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ORGANON TEKNIKA CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/04/1984
Decision Date 08/02/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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