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510(k) K921391

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1992
Date Received
March 23, 1992
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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  • K941453 — CHECK VALVE SOLUTION SET (August 16, 1994)
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  • K932637 — SUBCUTANEOUS INFUSION SET (January 7, 1994)
  • K931659 — 3 LEAD CONNECTOR (January 7, 1994)
  • K931658 — IN-LINE BURETTE SET (December 21, 1993)

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