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510(k) K063160

Device
ALLERGEAZE PATCH TEST CHAMBERS
Applicant
SMART PRACTICE
510(k) number
K063160
Product code
LDH  
Decision
Substantially Equivalent (SESE)
Decision date
2006-12-22
Date received
2006-10-17
Regulation
510(k) Premarket Notification
Classification name
System, Delivery, Allergen And Vaccine
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
KIM SULLIVAN
Address
3400 E. Mcdowell Rd. Phoenix AZ US 85008 85008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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