The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Dermabrader.
Device ID | K905046 |
510k Number | K905046 |
Device Name: | DERMABRADER |
Classification | Brush, Dermabrasion, Powered |
Applicant | AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg, FL 33712 |
Contact | Robert Saron |
Correspondent | Robert Saron AARON MEDICAL INDUSTRIES 1640 CENTRAL AVE. St. Petersburg, FL 33712 |
Product Code | GFE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-08 |
Decision Date | 1990-12-19 |