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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device respiratory accessory microbial reduction device.
Definition A respiratory accessory microbial reduction device is a home-use device intended to be used as an adjunct for microbial reduction of compatible respiratory accessories,such as hoses and masks,after cleaning. This device is not intended to replace the original accessory manufacturer’s cleaning instructions.
Product CodeQXQ
Regulation Number 880.6993
Device Class 2


Premarket Reviews
ManufacturerDecision
SOCLEAN, INC.
  GRANTED 1

Recalls
Manufacturer Recall Class Date Posted
1 SoClean, Inc II Jan-10-2024
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