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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endoscope, rigid
Regulation Description Endoscope and accessories.
Product CodeGCM
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Component(s), broken 2
No Known Device Problem 2
Material fragmentation 1
Loss of or failure to bond 1
Break 1
Total Device Problems 7

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