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510(k) K871583

MODIFIED LABELING FOR AMUKIN-50% by Amuchina Intl., Inc. — Product Code KDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1987
Date Received
April 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, For Peritoneal Dialysis, Disposable
Device Class
Class II
Regulation Number
876.5630
Review Panel
GU
Submission Type

Other clearances by Amuchina Intl., Inc.

  • K992016 — AMUKIN D (January 10, 2000)
  • K952302 — AMUCHINA (July 26, 1995)
  • K862928 — AMUKIN-50% FOR CAPD Y-SET (March 9, 1987)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)

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  • K173593 — stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter ext (May 21, 2018)
  • K173651 — Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set (February 14, 2018)
  • K173363 — Cycler Drain Bag Set (January 24, 2018)
  • K151620 — Firefly Peritoneal Dialysis Connector Disinfection System (January 20, 2016)
  • K152129 — FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iod (October 29, 2015)
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