The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Burr, Corneal, Battery-powered.
| Device ID | K950520 |
| 510k Number | K950520 |
| Device Name: | BURR, CORNEAL, BATTERY-POWERED |
| Classification | Burr, Corneal, Battery-powered |
| Applicant | AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Contact | J. R Saron |
| Correspondent | J. R Saron AARON MEDICAL INDUSTRIES 7100 30TH AVE. NORTH St. Petersburg, FL 33710 |
| Product Code | HOG |
| CFR Regulation Number | 886.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-05-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841668113165 | K950520 | 000 |
| 00841668113158 | K950520 | 000 |
| 00841668113141 | K950520 | 000 |
| 00841668113127 | K950520 | 000 |