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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tape, measuring, rulers and calipers
Regulation Description Manual surgical instrument for general use.
Product CodeFTY
Regulation Number 878.4800
Device Class 1


Premarket Reviews
ManufacturerDecision
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
MICK RADIO-NUCLEAR INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIC SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
PFIZER
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Lemaitre Vascular, Inc. III Nov-22-2010
2 SpineFrontier, Inc. II Apr-21-2015

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