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510(k) K851675

Device
THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE
Applicant
LINGEMAN MEDICAL PRODUCTS, INC.
510(k) number
K851675
Product code
EYY  
Decision
Substantially Equivalent (SESE)
Decision date
1985-05-14
Date received
1985-04-23
Regulation
878.4370
Classification name
Drape, Urological, Disposable
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL LINGEMAN
Address
3401 Xenia Cir. Indianapolis IN US 46227 46227

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
K810291STERILE/DISPOSABLE HSG TRAYUnimar, Inc.1981-03-18

Legacy Summary#

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FDA Review#

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