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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device marker, skin
Regulation Description Skin marker.
Product CodeFZZ
Regulation Number 878.4660
Device Class 1


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
SCANLAN
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Unknown (for use when the device problem is not known) 6
Other (for use when an appropriate device code cannot be identified) 4
Patch test, abnormal results of 1
Total Device Problems 11

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