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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wound dressing kit
Regulation Description Elastic bandage.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeMCY
Regulation Number 880.5075
Device Class 2

Device Problems
Patient-Device Incompatibility 1
Adhesive 1
Total Device Problems 2

Recalls
Manufacturer Recall Class Date Posted
1 Customed, Inc II Apr-14-2016
2 Customed, Inc II Sep-03-2015

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