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510(k) K823622

Device
INSULATED THERMOELASTOMER MITT
Applicant
FRED SAMMONS, INC.
510(k) number
K823622
Product code
IMA  
Decision
Substantially Equivalent (SESE)
Decision date
1982-12-30
Date received
1982-12-06
Regulation
890.5730
Classification name
Pack, Heat, Moist
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IMA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K150139Rachel's RemedyRachel'S Remedies, LLC2015-05-22
K950701WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLERWahl Clipper Corp.1995-03-24
K841698HEAT PACKMaddak, Inc.1984-05-10
K832803STEAM PAK MOIST HEATElectro-Med Health Industries, Inc.1983-09-20
K803177MOIST HEAT PACKDuro-Med Ind., Inc.1980-12-31
K791653REUSABLE MOIST HEAT PACKTru-Eze Mfg. Co., Inc.1979-09-07
K790904STAO-HOTPACKStaodynamics, Inc.1979-05-18

Legacy Summary#

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FDA Review#

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