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510(k) K873792

SEPACELL R-500 AND SEPACELL R-500A by Advocacy International, Ltd. — Product Code CAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 1988
Date Received
September 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Microfilter, Blood Transfusion
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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  • K854259 — SEPACELL R-500 & SEPACELL R-500A (January 8, 1986)
  • K842103 — TOYO JOZO URIC ACID TEST (August 12, 1984)
  • K842104 — TOYO JOZO G-GTP TEST (August 10, 1984)
  • K830183 — ASAHI HOLLOW FIBER KIDNEYS NR SERIES (March 17, 1983)
  • K830231 — ASAHI HOLLOW FIBER KIDNEYS, AM-SERIES (March 17, 1983)
  • K823733 — EIKEN KIZAI ARTIFICIAL KIDNEY BLOOD CIR (January 14, 1983)
  • K813037 — FLOWGUARD CATHETERS & CANNALAE (December 14, 1981)

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