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510(k) K943421

Device
ORTHODONITC ELASTOMERIC SLEEVING
Applicant
JON-KO PRODUCTS, INC.
510(k) number
K943421
Product code
DZD  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-23
Date received
1994-07-15
Regulation
872.5410
Classification name
Tube, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN M MARNELLA
Address
10250 Camino Santa Fe San Diego CA US 92121 92121

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
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
K834446ALEXOTEK LINGUAL TUBESAlexotek Co.1984-04-05
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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