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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscopic bite block
Regulation Description Endoscope and accessories.
Definition To prevent patient from biting down in order to protect fragile endoscope equipment, patient's teeth and gums, and endscopist's fingers when inserting endoscope orally.
Product CodeMNK
Regulation Number 876.1500
Device Class 1


Premarket Reviews
ManufacturerDecision
GI SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
SUPERIOR HEALTHCARE GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 2
Material fragmentation 1
Material separation 1
Device operates differently than expected 1
Total Device Problems 5

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