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510(k) K970946

MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET by Medline Industries, Inc. — Product Code LJH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1997
Date Received
March 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Irrigation, Urological
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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Other clearances for product code LJH

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  • K062551 — NEXUS IRRIGATION TUBING SET (December 15, 2006)
  • K042457 — URO PRO (October 25, 2004)
  • K040094 — PIGGYBACK IRRIGATING SYSTEM (April 15, 2004)
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