The following data is part of a premarket notification filed by Aaron Medical Industries with the FDA for Hi-tip High Temperature Replacement Tip.
| Device ID | K945758 |
| 510k Number | K945758 |
| Device Name: | HI-TIP HIGH TEMPERATURE REPLACEMENT TIP |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-01 |
| Decision Date | 1995-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925000483 | K945758 | 000 |
| 00887482179550 | K945758 | 000 |
| 00887482179574 | K945758 | 000 |
| 00887482179598 | K945758 | 000 |
| 00887482179611 | K945758 | 000 |
| 00887482179635 | K945758 | 000 |
| 00887482179659 | K945758 | 000 |
| 00887482179673 | K945758 | 000 |
| 00887482179697 | K945758 | 000 |
| 00887482179710 | K945758 | 000 |
| 00887482179734 | K945758 | 000 |
| 00887482179758 | K945758 | 000 |
| 00821925000476 | K945758 | 000 |
| 00887482179536 | K945758 | 000 |