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510(k) K993951

Device
SPOT ENDOSCOPIC MARKER
Applicant
CHEK-MED SYSTEMS
510(k) number
K993951
Product code
NBG  
Decision
Substantially Equivalent (SESE)
Decision date
2000-02-18
Date received
1999-11-22
Regulation
876.1500
Classification name
Marker, Colon
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROB WHALEN
Address
11 Phelps Way P.O. Box 289 Willington CT US 06279 06279

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code NBG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K042901ENDOMARK STERILE INDIA INKPmt Corp.2005-03-16

Legacy Summary#

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FDA Review#

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