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510(k) K200893

ProntoPump Sterile Tube Set by Ipax, Inc. — Product Code LHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 2021
Date Received
April 3, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Ipax, Inc.

  • K971242 — BLINK GOLD EVELID WEIGHT (BG 06 THRU BG 28) (December 17, 1997)
  • K971245 — BLINK EXTERNAL EYELID WEIGHT (June 20, 1997)
  • K915158 — SUREBREATH DOME, E-Z BREATHER (February 12, 1992)
  • K915118 — PHACO EMULSIFICATION,IRRIGATION/ASPIRATION TUBE (December 27, 1991)
  • K914172 — KPE 230 AM (October 25, 1991)
  • K914221 — KPE 220 TS, NONSTERILE (October 25, 1991)
  • K884076 — SUREBREATH DOME (October 7, 1988)
  • K873097 — PROCEDUAL CHANGES/ASSEMBLY PROCESS FOR PLUS PAKS (September 4, 1987)
  • K870770 — TIMLEINE(TM) VENIPUNCTURE SYSTEM (April 23, 1987)
  • K864726 — I/A/KPE TIP (January 20, 1987)

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