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510(k) K821801

Device
NORSEN DEBRIDER
Applicant
BEL-MED, INC.
510(k) number
K821801
Product code
GED  
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-28
Date received
1982-06-15
Regulation
878.4800
Classification name
Brush, Dermabrasion, Manual
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
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 GED  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K830259PROTET SOAP & WASH MITTRitmed, Inc.1983-05-09

Legacy Summary#

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FDA Review#

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