The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Standard & Extended Blade/needle/ball;modified Standard & Extended Blade/needle.
| Device ID | K971187 |
| 510k Number | K971187 |
| Device Name: | STANDARD & EXTENDED BLADE/NEEDLE/BALL;MODIFIED STANDARD & EXTENDED BLADE/NEEDLE |
| Classification | Electrode, Electrosurgical |
| 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 | JOS |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-01 |
| Decision Date | 1997-05-05 |