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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device polymer, ent synthetic-polyamide (mesh or foil material)
Regulation Description Ear, nose, and throat synthetic polymer material.
Product CodeKHJ
Regulation Number 874.3620
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK BIOTECH INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 3 3
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Expiration Date Error 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Patient Device Interaction Problem 1 1
Product Quality Problem 1 1
Device Appears to Trigger Rejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Local Reaction 1 1
Insufficient Information 1 1
Partial Hearing Loss 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Biotech, Inc. II Jan-10-2025
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