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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device kit, first aid, talking
Regulation Description Nonresorbable gauze/sponge for external use.
Definition The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient.
Product CodeOVR
Regulation Number 878.4014
Device Class 1

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