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510(k) K791162

Device
GELSKIN
Applicant
SPENCO MEDICAL CORP.
510(k) number
K791162
Product code
ILO  
Decision
Substantially Equivalent (SESE)
Decision date
1979-09-04
Date received
1979-06-25
Regulation
890.5720
Classification name
Pack, Hot Or Cold, Water Circulating
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
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 ILO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K213097Armory MotionPain Management Technologies, Inc.2022-06-10
K083008COOLSKINElbio Co., Ltd.2009-06-10
K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.2008-05-08
K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.2007-09-07
K070402MODIFICATION TO POLAR CARE 500Breg, Inc.2007-03-29
K040317IVC SYSTEMMark H. Friedman2004-05-07
K973023INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKETHollister, Inc.1997-11-03
K970197HTP-1500 LOCALIZED HEAT THERAPY PUMPAdroit Medical Systems, Inc.1997-09-10
K964354ARTOCOOL-S WATER CIRCULATING COLD PACKOrmed GmbH1997-08-29
K964799ARTROTHERM CRYOTHERAPY AND THERNOTHERAPYOrmed GmbH1997-08-29
K964710BLEDSOE COLD CONTROLMed Technology, Inc.1997-05-09
K970533MODEL 1100 COLD THERAPY DEVICESmith & Nephew, Inc.1997-04-15
K962983STERILE SOFT-TEMPAdroit Medical Systems, Inc.1997-01-10
K964006INCARE HOT/ICE SYSTEM BLANKETS (VARIOUS SIZES AND SHAPES)Hollister, Inc.1996-12-31
K964057INCARE HOT/ICE SYSTEM SHOULDER BLANKETHollister, Inc.1996-12-31

Legacy Summary#

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FDA Review#

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