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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retractor, ent
Regulation Description Ear, nose, and throat manual surgical instrument.
Product CodeKAL
Regulation Number 874.4420
Device Class 1


Premarket Reviews
ManufacturerDecision
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 1
Total Device Problems 1

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