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510(k) K841711

Device
MAC LEE SITZ BATH
Applicant
MAC LEE MEDICAL PRODUCTS
510(k) number
K841711
Product code
KTC  
Decision
Substantially Equivalent (SESE)
Decision date
1984-05-07
Date received
1984-04-24
Regulation
890.5125
Classification name
Bath, Sitz, Nonpowered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
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 KTC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912179THE SPRITZ BATHThe Spritz Co.1991-08-28
K890085SIT-N-BATHE SITZ BATHDrummond Industries, Inc.1989-02-13
K862600SITZ BATHW. C. Green, D.D.S.1986-07-18
K851309ABCO PLASTIC UTENSILSAbco Dealers, Inc.1985-07-01
K831762SITZ BATH, SINGLE PATIENT USE #8100Lsl Industries, Inc.1983-06-24
K800958PERSONAL SITZ BATH KITThe Healthcare Group Laboratories, Inc.1980-05-02

Legacy Summary#

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FDA Review#

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