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510(k) K760360

Device
SHIRT, MITTEN CUFF INFANT
Applicant
PRECEPT, INC.
510(k) number
K760360
Product code
FME  
Decision
Substantially Equivalent (SESE)
Decision date
1976-10-20
Date received
1976-08-02
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#

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 FME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K880385KIMBERLY-CLARK PROFESSIONAL JACKETKimberly-Clark Corp.1988-02-19
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

Legacy Summary#

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FDA Review#

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