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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device oximeter, reprocessed
Definition same as DQA except reprocessed. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).
Product CodeNLF
Regulation Number 870.2700
Device Class 2


Premarket Reviews
ManufacturerDecision
MASIMO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
MIDWEST REPROCESSING CENTER LLC
  SUBSTANTIALLY EQUIVALENT 1
RENU MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL INSTRUMENT AND SAVINGS INC (DBA MEDLINE RENEWAL)
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1

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