510(k) K760995

Device
DECOLLATING TRAY
Applicant
Dravon Medical, Inc.
510(k) number
K760995
Product code
FJZ
Decision
Substantially Equivalent (SESE)
Decision date
1977-01-06
Date received
1976-11-08
Regulation
876.5820
Classification name
Declotting Tray, Kit (Including Contents)
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FJZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821313SURGICAL UTILITY DRAPEMegaplast, Inc.1982-06-21
K821666STERILE SURGICAL DRAPESPhoenix Glove Co.1982-06-21