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510(k) K892218

Device
ENDO-SPONGE
Applicant
ENDOVATIONS
510(k) number
K892218
Product code
MNL  
Decision
Substantially Equivalent (SESE)
Decision date
1989-05-31
Date received
1989-04-03
Regulation
876.1500
Classification name
Accessories, Cleaning Brushes, For Endoscope
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
SUSAN P BJORKMAN
Address
Rossmoyne Industrial Park 5020 Ritter Rd., Suite 211 Mechanicsburg PA US 17055 17055

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MNL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950689UCBCox Medical Ent., Inc.1995-03-06
K946293MILL-ROSE SCOPE CLEANING BRUSHMill-Rose Laboratory1995-02-16
K874239CLEANING BRUSHEndovations1987-12-29

Legacy Summary#

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FDA Review#

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