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510(k) K851309

Device
ABCO PLASTIC UTENSILS
Applicant
ABCO DEALERS, INC.
510(k) number
K851309
Product code
KTC  
Decision
Substantially Equivalent (SESE)
Decision date
1985-07-01
Date received
1985-04-02
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#

Contact
CHRISTINE MEMETH
Address
P.O. Box 17587 6637 N. Sidney Pl. Milwaukee WI US 53217 53217

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
K841711MAC LEE SITZ BATHMac Lee Medical Products1984-05-07
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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