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510(k) K810291

Device
STERILE/DISPOSABLE HSG TRAY
Applicant
UNIMAR, INC.
510(k) number
K810291
Product code
EYY  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-18
Date received
1981-02-03
Regulation
878.4370
Classification name
Drape, Urological, Disposable
Medical specialty
General & Plastic Surgery
Review panel
Radiology
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 EYY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K851675THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPELingeman Medical Products, Inc.1985-05-14

Legacy Summary#

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FDA Review#

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