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510(k) K941453

CHECK VALVE SOLUTION SET by Douglas Medical Products Corp. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1994
Date Received
March 25, 1994
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 Douglas Medical Products Corp.

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  • K961155 — SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 (June 18, 1996)
  • K954428 — SOLOPICC 24 (60CM) 20GA CATHETER (March 28, 1996)
  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K942101 — 4-LEAD IRRIGATION SET (September 30, 1994)
  • K930854 — SOLUTION SET WITH .2 MICRON FILTER (January 14, 1994)
  • K931659 — 3 LEAD CONNECTOR (January 7, 1994)
  • K932637 — SUBCUTANEOUS INFUSION SET (January 7, 1994)
  • K931658 — IN-LINE BURETTE SET (December 21, 1993)
  • K932638 — HUBER NEEDLE INFUSION SET (December 14, 1993)

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