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510(k) K831899

Device
ENSWELL
Applicant
DR. MICHEAL A. SABIA
510(k) number
K831899
Product code
IME  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-07
Date received
1983-06-14
Regulation
890.5700
Classification name
Pack, Hot Or Cold, Reusable
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 IME  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K923627COLD PACKFriendmed Products1993-04-14
K915876HOTPADTen Comfort Corp.1993-02-12
K921446HOT OR COLD PACK (THERMIPAQ)Thermionics Corp.1992-07-13
K905207MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESSMicro Surgical Instruments Corp.1991-01-22
K882413SUBOCCIPITAL ICE PILLOWFerguson Medical1988-11-30
K863654RE-HEATER, HOT PACKK & L Ent.1986-10-23
K832193NICE PACKUniversal Medical Instrument Corp.1983-08-31
K830981MICROPAK MOIST HEAT PADMicropak Manufacturers, Inc.1983-06-03
K830416ICY COLD ICE CAPLadora Ent.1983-03-10
K823649THERMOELASTOMER HOT/COLD COMPRESS BK7186Fred Sammons, Inc.1983-01-21
K823650THERMOELASTOMER HOT/COLD COMPRESS-7187-Fred Sammons, Inc.1983-01-21
K823814HOT/COLD PACK HOLDERSDanek Medical, Inc.1983-01-14
K822783FLEX ICE FREEZE PACKIgloo Corp.1982-10-06
K821636ATTACH-A-PAKFred Sammons, Inc.1982-06-11
K820901COLD ROLLNorth Bank Labs, Inc.1982-04-15

Legacy Summary#

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FDA Review#

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