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510(k) Survey

Results of June 2008 Survey on 510(k) Submission Practices and FDA Clearances

Conducted by Compliance-Alliance
and Certified Compliance Solutions

Products Categories Number of
Responses
All responses 235
Anesthesiology devices 28
Cardiovascular devices 62
Clinical chemistry devices 20
Dental devices 19
Ear nose and throat devices 15
Gastroenterology-urology devices 25
General and plastic surgery devices 39
General hospital and personal use devices 51
Hematology and pathology devices 20
IVDs 62
Neurological devices 22
Obstetrical and gynecological devices 21
Ophthalmic devices 18
Orthopedic devices 31
Physical medicine devices 9
Radiological devices 45
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