The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Bipolar Hf Device.
| Device ID | K110695 |
| 510k Number | K110695 |
| Device Name: | BIPOLAR HF DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle AESCULAP, INC. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-06-28 |
| Summary: | summary |