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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device ear irrigation kit
Regulation Description Irrigating syringe.
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 CodeOGQ
Regulation Number 880.6960
Device Class 1

MDR Year MDR Reports MDR Events
2018 1 1
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1 1
Device Dislodged or Dislocated 1 1
Tip 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hearing Loss 1 1
Unspecified Infection 1 1
Pain 1 1
Tissue Damage 1 1

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