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510(k) K891589

Device
3MM DISPOSABLE SPECULA
Applicant
SEMANTODONTICS, INC.
510(k) number
K891589
Product code
FXG  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-18
Date received
1989-03-20
Regulation
878.1800
Classification name
Specula Accessories
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DANIEL F ENRIQUEZ
Address
3400 E. Mcdowell Rd. Phoenix AZ US 85008 85008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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