FDA 510(k), K160749, CRIT-LINE III Blood Chamber II
FDA 510(k), K160749, CRIT-LINE III Blood Chamber II
510(K) Number: K160749
Device Name: CRIT-LINE III Blood Chamber II
Manufacturer: Denise Oppermann
Device Classification Name: Accessories, Blood Circuit, Hemodialysis
Regulation Number: KOC
Classification Product Code: KXA
Date Received: 03/18/2016
Decision Date: 04/15/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Total pages: 480
Fully redacted pages: 252
Content pages: 228
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