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510(k) K895092

Device
KUT-SHIELD
Applicant
KUT-GUARD, INC.
510(k) number
K895092
Product code
FYH  
Decision
Substantially Equivalent (SESE)
Decision date
1989-09-26
Date received
1989-08-14
Regulation
878.3910
Classification name
Splint, Extremity, Noninflatable, External, Sterile
Medical specialty
General & Plastic Surgery
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WIN HIRSCH
Address
P.O. Box 6402 Hollywood FL US 33081 33081

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FYH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K925145TRACE MODEL #'S 840, 841, 842, 845Trace Medical Equipment, Inc.1993-05-19
K924984SPECIALIST(R) WALKERJohnson & Johnson Orthopaedics, Inc.1993-02-01
K852558SPLINTS(ALL TYPE)The Huxley Instrument Corp.1985-07-02
K843400HYDRO-SPLINT A SPONGE-COMPRESS DRESSCompression Splint Products, Inc.1984-10-24
K821693J & J DIP WATER ADDITIVEJohnson & Johnson Professionals, Inc.1982-07-02
K802522DELTA-LITE CASTING TAPE & SPLINTSJohnson & Johnson Professionals, Inc.1981-01-08
K801436ORTHOPEDIC LOWER EXTREMITY SUSPENSIONOrthopedic Systems, Inc.1980-06-26

Legacy Summary#

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FDA Review#

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