The following data is part of a premarket notification filed by Ion Medical, Llc with the FDA for Ion Medical Bipolar Coagulation Pen.
| Device ID | K072911 |
| 510k Number | K072911 |
| Device Name: | ION MEDICAL BIPOLAR COAGULATION PEN |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ION MEDICAL, LLC 6900 PHILIPS HIGHWAY SUITE 41 Jacksonville, FL 32216 |
| Contact | Keith Huron |
| Correspondent | Keith Huron ION MEDICAL, LLC 6900 PHILIPS HIGHWAY SUITE 41 Jacksonville, FL 32216 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-12 |
| Decision Date | 2007-12-13 |
| Summary: | summary |