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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device elastomer, silicone block
Regulation Description Ear, nose, and throat synthetic polymer material.
Product CodeMIB
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
IMPLANTECH ASSOCIATES INC.
  SUBSTANTIALLY EQUIVALENT 2
SILIMED
  SUBSTANTIALLY EQUIVALENT 4
SPECIALTY SURGICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 2
Implant, removal of 1
Total Device Problems 3

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