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510(k) K021976

FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON by Vital Scientific N.V. — Product Code KQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2002
Date Received
June 17, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

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  • K020840 — VITAL SCIENTIFIC PT WITH CALCIUM (May 15, 2002)
  • K973628 — VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (March 13, 1998)

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