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510(k) K880384

Device
KIMBERLY-CLARK X-TRA TRACTION IMPERVIOUS BOOT
Applicant
KIMBERLY-CLARK CORP.
510(k) number
K880384
Product code
BWP  
Decision
Substantially Equivalent (SESE)
Decision date
1988-06-23
Date received
1988-01-28
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#

Contact
CYNTHIA E SMITH
Address
1400 Holcomb Bridge Rd. Roswell GA US 30076 30076

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
K831952SURGICAL APPAREL SHOE COVERSSudreca Surgical Dressings, Inc.1983-07-12
K812105ANOGO DISPOSABLE SHOE COVERAnago, Inc.1981-09-11

Legacy Summary#

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FDA Review#

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