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510(k) K872488

Device
ELASTO-GEL CAST & SPLINT PADS
Applicant
SOUTHWEST TECHNOLOGIES, INC.
510(k) number
K872488
Product code
IPM  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1987-09-21
Date received
1987-06-23
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#

Contact
EDWARD I STOUT
Address
1510 Charlotte Kansas City MO US 64108 64108

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
K823399COVER LIMBOrthopedic Systems, Inc.1982-11-29
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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