The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for 3rd Hand Helper.
| Device ID | K911815 |
| 510k Number | K911815 |
| Device Name: | 3RD HAND HELPER |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-24 |
| Decision Date | 1991-08-02 |