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510(k) K961049

FLEX NEEDLE by Lighthouse Medical, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1996
Date Received
March 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Lighthouse Medical, Inc.

  • K960230 — SNARE (July 31, 1996)
  • K960231 — SPHINCTEROTOME (July 31, 1996)
  • K954121 — CYTOLOGY BRUSH (October 7, 1995)

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