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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device suture, absorbable, natural
Regulation Description Absorbable surgical gut suture.
Product CodeGAL
Regulation Number 878.4830
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ARC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEMETECH CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
SERRAL, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
SUTURTEK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
UNITED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS 3

Device Problems
Break 37
Other (for use when an appropriate device code cannot be identified) 36
Reaction 11
Implant extrusion 6
Absorption 3
Needle, separation 2
Total Device Problems 95

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