510(k) K120247

Device
EASYDEX
Applicant
VINELAND SYRUP INC.
510(k) number
K120247
Product code
MRV  
Decision
Substantially Equivalent (SESE)
Decision date
2012-06-21
Date received
2012-01-27
Regulation
862.1345
Classification name
Drink, Glucose Tolerance
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ERIC FEERST
Address
57 Hartford Rd. Sewell NJ US 08080 08080

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRV  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042183GLUCOSE TOLERANCE BEVERAGEEver Scientific2004-10-27
K032753GLUCOSE TOLERANCE BEVERAGEPerk Scientific, Inc.2003-11-18

Legacy Summary#

summary

FDA Review#

Decision Summary