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510(k) K880385

Device
KIMBERLY-CLARK PROFESSIONAL JACKET
Applicant
KIMBERLY-CLARK CORP.
510(k) number
K880385
Product code
FME  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-19
Date received
1988-01-28
Regulation
880.6265
Classification name
Gown, Examination
Medical specialty
General Hospital
Review panel
General Hospital
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 FME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K811915MONITOR/VITAL SIGNS TRAYAmerican Hospital Supply Corp.1981-07-28
K770476EXAM GOWNGeneral Medical Co.1977-05-06
K760954CROWNTEX EXAM. CAPE & GOWNGraham Manufacturing Co.1976-12-30
K760360SHIRT, MITTEN CUFF INFANTPrecept, Inc.1976-10-20

Legacy Summary#

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FDA Review#

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