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510(k) K172062

Device
AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
Applicant
MedScience Science Research Group, Inc.
510(k) number
K172062
Product code
LDH  
Decision
Substantially Equivalent (SESE)
Decision date
2018-03-05
Date received
2017-07-07
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
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Marvin Smollar
Address
16469 Bridlewood Cir. Delray Beach FL US 33445 33445

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

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