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510(k) K834446

Device
ALEXOTEK LINGUAL TUBES
Applicant
ALEXOTEK CO.
510(k) number
K834446
Product code
DZD  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-05
Date received
1983-12-16
Regulation
872.5410
Classification name
Tube, Orthodontic
Medical specialty
Dental
Review panel
Dental
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 DZD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K943421ORTHODONITC ELASTOMERIC SLEEVINGJon-Ko Products, Inc.1995-05-23
K936243REGENCY TUBEOrtho Specialties1994-02-02
K935143DENTAURUM STAINLESS STEEL TUBINGDentauraum, Inc.1994-01-31
K911399NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)Aequitron Medical, Inc.1991-09-19
K896586RATE INCREASE FOR IPPB/IPVPercussionaire Corp.1990-01-09
K834392LABIAL CUSPID TUBEAlexotek Co.1984-02-28
K780205ORTHODONTIC BUCCAL TUBERocky Mountain Orthodontics, Inc.1978-02-16

Legacy Summary#

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FDA Review#

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