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510(k) K905046

Device
DERMABRADER
Applicant
AARON MEDICAL INDUSTRIES
510(k) number
K905046
Product code
GFE  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-19
Date received
1990-11-08
Regulation
878.4820
Classification name
Brush, Dermabrasion, Powered
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
ROBERT SARON
Address
1640 Central Ave. St. Petersburg FL US 33712 33712

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GFE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K963204DMS-1000C DERMOABRADERAesthetic Lasers, Inc.1996-12-09

Legacy Summary#

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FDA Review#

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