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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sigmoidoscope And Accessories, Flexible/Rigid
510(k) Number K792314
Device Name RID SYSTEMS - ALPH-1-ACID GLYCOPROTEIN
Applicant
ICL SCIENTIFIC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
ICL SCIENTIFIC
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number876.1500
Classification Product Code
FAM  
Date Received11/16/1979
Decision Date 12/06/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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