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510(k) K963889

QFC UMBILICAL CLAMP by Qfc Industries — Product Code HFW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1997
Date Received
September 26, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Umbilical
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

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  • K000227 — UMBICUT (April 27, 2000)
  • K994367 — UMBILICAL CORD CLAMP (March 17, 2000)