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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter care tray (kit)
Regulation Description Urological catheter and accessories.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOHR
Regulation Number 876.5130
Device Class 2

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 2 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Apogee Medical, Inc II May-03-2011
2 Medical Device Technologies, Inc. II Nov-18-2011

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