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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device barrier, std, oral sex
Product CodeMSC
Regulation Number 884.5300
Device Class 2


Premarket Reviews
ManufacturerDecision
BRAZEN GOODS INC. DBA LORALS
  SUBSTANTIALLY EQUIVALENT 1
LINE ONE LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAMCO DISTRIBUTING INC.
  SUBSTANTIALLY EQUIVALENT 1
SANCTUARY HEALTH SDN. BHD.
  SUBSTANTIALLY EQUIVALENT 1

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