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510(k) K962670

NHMC IRRIGATION TRAY by National Healthcare Mfg. Corp. — Product Code LJH

K962670 is an FDA 510(k) premarket notification submitted by National Healthcare Mfg. Corp. for the device "NHMC IRRIGATION TRAY". The FDA issued a decision of Substantially Equivalent on August 14, 1996. The device falls under product code LJH (System, Irrigation, Urological), a Class II device regulated under 21 CFR 876.5130. National Healthcare Mfg. Corp. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 14, 1996
Date Received
July 9, 1996
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

Other clearances by National Healthcare Mfg. Corp.

  • K972013 — NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PACKS (August 26, 1997)
  • K971465 — NATIONAL MEDICAL HALTHCARE CUSTOM OPHTHALMIC KITS OR TRAYS (June 4, 1997)
  • K971317 — NATIONAL MEDICAL HEALTHCARE CUSTOM ORTHOPEDIC KITS AND TRAYS (May 8, 1997)
  • K962254 — NHMC URETHRAL CATHETERIZATION TRAY (July 29, 1996)
  • K960523 — NHMC DRESSING TRAY (April 4, 1996)
  • K960566 — NHMC FOLEY CATHETERIZATION TRAY (February 29, 1996)

Other clearances for product code LJH

  • K162992 — Karl Storz UROMAT E.A.S.I. (July 7, 2017)
  • K070873 — AMSURE BLADDER IRRIGATION SET (December 19, 2007)
  • K071832 — MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM (September 18, 2007)
  • K063700 — SPYGLASS IRRIGATION SYSTEM (February 8, 2007)
  • K062551 — NEXUS IRRIGATION TUBING SET (December 15, 2006)
  • K042457 — URO PRO (October 25, 2004)
  • K040094 — PIGGYBACK IRRIGATING SYSTEM (April 15, 2004)
  • K023808 — IRRIGATION SETS (March 10, 2003)
  • K010607 — MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 (November 28, 2001)
  • K010122 — CONTINUOUS FLOW Y-TUBING (June 4, 2001)

FDA data resources