FDA.reportPublic FDA data

510(k) K840107

Device
TUBE-BANDAGE FOR HUMAN DIGITS 200
Applicant
Zens Health Care Products
510(k) number
K840107
Product code
FQM
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-25
Date received
1984-01-10
Regulation
880.5075
Classification name
Bandage, Elastic
Medical specialty
General Hospital
Review panel
General Hospital
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 FQM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040936PETIT SILMA ELASTIC BANDAGE WITH GERMANIUM/TITANIUM OXIDELeda Co., Ltd.2004-05-03
K040054BACK IN ACTION COMPRESSION & SUPPORT WITH MAGNETS FOR THE LOWER BACK, KNEE AND ANKLETheodore Barash2004-04-27
K013244COMFORTCARE COMPRESSION SUPPORT WITIH MAGNETS AND AEGIS MICROBE SHIELD COMFORTCARE MAGNETIC INSOLES AND AEGIS MICROBEMed Gen, Inc.2001-12-07
K952738SKIN SAVER SYSTEMSSkin Saver Systems, Inc.1995-09-29
K872868ASPEN ESMARK BANDAGEAspen Laboratories, Inc.1987-07-31
K831728MEDICALEXMedicalex1984-01-09
K830622ORTHO WRAPFast Wrap Co., Inc.1983-06-20
K831551COMPRESSOGRIP TUBULAR ELASTIC BANDAGEFred Sammons, Inc.1983-06-07
K820141BIAS STOCKINETTEStan-Pak Ent.1982-02-05
K820142TUBULAR STOCKINETTEStan-Pak Ent.1982-02-05
K820094ELASTIC BANDAGEStan-Pak Ent.1982-01-29
K811173STRUVA & MEDIWeco1981-06-18
K810137SOF-BAND HIGH STRETCH BANDAGESJohnson & Johnson Professionals, Inc.1981-02-17
K802991ROLL STRETCH GAUZEAbco Dealers, Inc.1980-12-30
K802992ELASTIC GAUZEAbco Dealers, Inc.1980-12-30