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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dilator, vaginal
Product CodeHDX
Regulation Number 884.3900
Device Class 2


Premarket Reviews
ManufacturerDecision
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LUJENA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MATERNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
PANPAC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
PLUS EV HOLDINGS DBA INTIMATE ROSE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Jul-17-2015
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