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510(k) K931658

IN-LINE BURETTE SET by Douglas Medical Products Corp. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1993
Date Received
April 5, 1993
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

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  • K941628 — 40 MICRON BLOOD TRANSFUSION FILTER (February 16, 1995)
  • K942101 — 4-LEAD IRRIGATION SET (September 30, 1994)
  • K941453 — CHECK VALVE SOLUTION SET (August 16, 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)
  • K932638 — HUBER NEEDLE INFUSION SET (December 14, 1993)

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