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510(k) K823399

Device
COVER LIMB
Applicant
ORTHOPEDIC SYSTEMS, INC.
510(k) number
K823399
Product code
IPM  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-29
Date received
1982-11-12
Regulation
890.3025
Classification name
Cover, Limb
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 IPM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872488ELASTO-GEL CAST & SPLINT PADSSouthwest Technologies, Inc.1987-09-21
K801627COVER, LIMBThe Owenby Co.1980-07-28
K780905LIMB COVERHydro-Med Products, Inc.1978-08-14
K770223HEAVY FOAM HEEL & ELBOW PROTECTORSRobert R. Moore1977-02-23
K761114FOAM SLIPPERSFred Sammons, Inc.1976-12-02

Legacy Summary#

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FDA Review#

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