FDA.reportPublic FDA data

510(k) K831706

Device
Sato Family First Aid Kit
Applicant
FOOD AND DRUG SERVICE, INC.
510(k) number
K831706
Product code
ILI
Decision
Substantially Equivalent (SESE)
Decision date
1983-06-24
Date received
1983-05-26
Regulation
890.3640
Classification name
Sling, Arm
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 ILI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K912661MATRX, PYRAMID TRIANGLE BANDAGEMatrix Medica, Inc.1991-08-21
K831549ARM SLINGSFred Sammons, Inc.1983-06-30
K823808VARIOUS ARM SLINGDanek Medical, Inc.1983-01-14
K823810A.C. SPLINTDanek Medical, Inc.1983-01-14
K823664UNIVERSAL SLING, SLING & SWATHEWarm & Form, Orthopedic Materials1982-12-30
K823162UNIVERSAL SLING, SLING & SWATHEWarm & Form, Orthopedic Materials1982-11-10
K820590ORTHOPEDIC SOFT GOODSAbco Dealers, Inc.1982-03-26
K812477ARM SLING, POUCH TYPEMaddak, Inc.1981-09-14
K812478MADDACOMFORT SLINGMaddak, Inc.1981-09-14
K812480LIMB HOLDER ARM SLINGMaddak, Inc.1981-09-14
K812345ARM SLINGSFred Sammons, Inc.1981-09-11
K803139CONPHAR ARM SLINGSConphar, Inc.1981-01-08
K803212BAUER & BLACK ARM SLING W/DETACH. POUCHBd Becton Dickinson Vacutainer Systems Preanalytic1981-01-08
K802006TRIANGULAR BANDAGE CAT.#191Pollak (Intl.), Ltd.1980-09-16
K801713BK-6157-02 C.V.A SLING, MEDIUM&LARGEFred Sammons, Inc.1980-08-07