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510(k) K862928

AMUKIN-50% FOR CAPD Y-SET by Amuchina Intl., Inc. — Product Code FKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 1987
Date Received
August 1, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Peritoneal, Automatic Delivery
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)
  • K871583 — MODIFIED LABELING FOR AMUKIN-50% (July 9, 1987)
  • K852359 — AMUCHINA/DIALYZER DISINFECTANT (May 13, 1986)

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