FDA.reportPublic FDA data

510(k) K801783

Device
Catheter Irrigation Trays, #3300, 3310 &
Applicant
THE HEALTHCARE GROUP LABORATORIES, INC.
510(k) number
K801783
Product code
EYN
Decision
Substantially Equivalent (SESE)
Decision date
1980-08-13
Date received
1980-07-28
Regulation
876.5980
Classification name
Tray, Irrigation, Sterile
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EYN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K944882IRRIGATION TRAYClinical Resources, Inc.1995-01-12
K923938IRRIGATION TRAY W/ PISTON SYRINGE & STERILE WATERAmerican Healthcare Corp.1993-06-17
K923939IRRIGATION TRAY W/ BULB SYRINGE & STERILE WATERAmerican Healthcare Corp.1993-06-17
K923940IRRIGATION TRAY W/ PISTON SYRINGE & STERILE SALINEAmerican Healthcare Corp.1993-06-17
K923941IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINEAmerican Healthcare Corp.1993-06-17
K900148KIT PAK IRRIGATION TRAYKit Pak, Inc.1990-04-23
K900737PISTON IRRIGATION TRAYOrion Life Systems, Inc.1990-04-19
K900736BULB IRRIGATION TRAYOrion Life Systems, Inc.1990-04-17
K792082GAVAGE FEEDING SETMedical Devices, Inc.1979-11-13
K791020FLUID ADMINISTRATION SET FA-3160Burron Medical Products, Inc.1979-06-27
K790607GREENLINE IRRIGATION TRAYSSnyder Laboratories, Inc.1979-05-11
K781918IRRIGATOR, BODY CAVITYBci, Inc.1979-02-15
K781748IRRIGATION TRAYIntermed, Inc.1978-12-12
K760047TRAY, BLADDER IRRIGATIONM-C Ind., Inc.1977-03-01