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510(k) K934069

MILLEX, DUALEX (PLUS, ULTRA) by Millipore Corp. — Product Code FIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1994
Date Received
August 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Transducer, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

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  • K914841 — CHROMATOGRAPHY CLINICAL USE 75JQR (December 10, 1991)
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  • K872792 — WATERS M600E MULTI-SOLVENT DELIVERY SYSTEM (July 31, 1987)

Other clearances for product code FIB

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  • K001971 — HEMODIALYSIS TUBING SETS (May 24, 2001)
  • K010264 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (April 27, 2001)
  • K001465 — NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING S (December 5, 2000)
  • K003445 — FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (December 1, 2000)
  • K000702 — BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (June 7, 2000)
  • K983076 — MEDISYSTEMS TRANSDUCER PROTECTOR (November 25, 1998)
  • K964337 — BETTER-BLADDER (BB) (May 23, 1997)
  • K970536 — MEDISYSTEMS TRANDUCER PROTECTOR (May 12, 1997)