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510(k) K963204

Device
DMS-1000C DERMOABRADER
Applicant
AESTHETIC LASERS, INC.
510(k) number
K963204
Product code
GFE  
Decision
Substantially Equivalent (SESE)
Decision date
1996-12-09
Date received
1996-08-15
Regulation
878.4820
Classification name
Brush, Dermabrasion, Powered
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
FRED DE JACMA
Address
528 College Pkwy., Suite C-1 Annapolis MD US 21401 21401

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
K905046DERMABRADERAaron Medical Industries1990-12-19

Legacy Summary#

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FDA Review#

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