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510(k) K802833

Device
TETRA NATAL-MAT WATER FLOTATION MAT.
Applicant
TETRA GROUP U.S.A., INC.
510(k) number
K802833
Product code
IKY  
Decision
Substantially Equivalent (SESE)
Decision date
1980-12-10
Date received
1980-11-12
Regulation
880.5150
Classification name
Mattress, Flotation Therapy, Non-powered
Medical specialty
General Hospital
Review panel
General Hospital
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 IKY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914921SCM-3 AND ACCESSORIESGaymar Industries, Inc.1992-03-12
K813226GEL FLOTATION MATTRESSJefferson Industries, Inc.1981-12-02
K802781BEDDING PADS EGGCREATE PADSLeemart Bedding Mfg. Co.1980-12-10
K780779ECONO-FLOAT WATER FLOTATION MATTRESSJefferson Industries, Inc.1978-05-19
K772062NEONATAL FLOTATION SYSTEMMedpro, Inc.1977-11-15
K771824MEDPRO FLOTATION SYSTEMMedpro, Inc.1977-10-19
K760963DECUBITUS MATTRESSArco Medical Products Co.1976-11-18

Legacy Summary#

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FDA Review#

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