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510(k) K923941

Device
IRRIGATION TRAY W/ BULB SYRINGE & STERILE SALINE
Applicant
AMERICAN HEALTHCARE CORP.
510(k) number
K923941
Product code
EYN  
Decision
Substantially Equivalent - Kit With Drugs (SEKD)
Decision date
1993-06-17
Date received
1992-08-05
Regulation
876.5980
Classification name
Tray, Irrigation, Sterile
Medical specialty
Gastroenterology/Urology
Review panel
General & Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RALPH S JARRETT
Address
One American Healthcare Plz. 3611 Kennedy Rd. South Plainfield NJ US 07080 07080

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
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
K801783CATHETER IRRIGATION TRAYS, #3300, 3310 &The Healthcare Group Laboratories, Inc.1980-08-13
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

Legacy Summary#

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FDA Review#

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