FDA.report

510(k) K051751

Device
EQUA-PULL SAFETY RELEASE MODULE
Applicant
Ortho Technology
510(k) number
K051751
Product code
DZB
Decision
Substantially Equivalent (SESE)
Decision date
2005-07-22
Date received
2005-06-29
Regulation
872.5500
Classification name
Headgear, Extraoral, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Related Records

Applicant Contact

Contact
STEVE KLAMIC
Address
17401 Commerce Park Blvd. Tampa FL US 33647 33647

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

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