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510(k) K823810

Device
A.C. SPLINT
Applicant
DANEK MEDICAL, INC.
510(k) number
K823810
Product code
ILI  
Decision
Substantially Equivalent (SESE)
Decision date
1983-01-14
Date received
1982-12-17
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
K831706SATO FAMILY FIRST AID KITFood and Drug Service, Inc.1983-06-24
K823808VARIOUS ARM SLINGDanek 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
K812480LIMB HOLDER ARM SLINGMaddak, Inc.1981-09-14
K812478MADDACOMFORT SLINGMaddak, Inc.1981-09-14
K812345ARM SLINGSFred Sammons, Inc.1981-09-11
K803212BAUER & BLACK ARM SLING W/DETACH. POUCHBd Becton Dickinson Vacutainer Systems Preanalytic1981-01-08
K803139CONPHAR ARM SLINGSConphar, Inc.1981-01-08
K802006TRIANGULAR BANDAGE CAT.#191Pollak (Intl.), Ltd.1980-09-16
K801713BK-6157-02 C.V.A SLING, MEDIUM&LARGEFred Sammons, Inc.1980-08-07

Legacy Summary#

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FDA Review#

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