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510(k) K841306

HEPARIN LOCK FLUSH SOLUTION USP KIT,100 by Solo Pak Laboratories — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1984
Date Received
March 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Solo Pak Laboratories

  • K851944 — MAX-I-PROBE HANDPIECE (July 1, 1985)
  • K841305 — HEPARIN LOCK FLUSH SOLUTION USP KIT (June 4, 1984)
  • K841166 — HEPARIN LOCK FLUSH PROCEDURE PACK (June 4, 1984)

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