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510(k) K812105

Device
ANOGO DISPOSABLE SHOE COVER
Applicant
ANAGO, INC.
510(k) number
K812105
Product code
BWP  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-11
Date received
1981-07-24
Regulation
878.4040
Classification name
Shoe And Shoe Cover, Conductive
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BWP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880384KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOTKimberly-Clark Corp.1988-06-23
K831952SURGICAL APPAREL SHOE COVERSSudreca Surgical Dressings, Inc.1983-07-12

Legacy Summary#

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FDA Review#

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