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510(k) K821313

Device
SURGICAL UTILITY DRAPE
Applicant
MEGAPLAST, INC.
510(k) number
K821313
Product code
FJZ  
Decision
Substantially Equivalent (SESE)
Decision date
1982-06-21
Date received
1982-05-04
Regulation
876.5820
Classification name
Declotting Tray, Kit (including Contents)
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

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FJZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K821666STERILE SURGICAL DRAPESPhoenix Glove Co.1982-06-21
K760995DECOLLATING TRAYDravon Medical, Inc.1977-01-06

Legacy Summary#

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FDA Review#

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