The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Sovereign Bipolar Instruments For Gynecology.
| Device ID | K003608 |
| 510k Number | K003608 |
| Device Name: | SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY |
| Classification | Electrocautery, Gynecologic (and Accessories) |
| Applicant | AESCULAP, INC. 944 MARCON BLVD. Allentown, PA 18109 |
| Contact | Lisa M Millington |
| Correspondent | Lisa M Millington AESCULAP, INC. 944 MARCON BLVD. Allentown, PA 18109 |
| Product Code | HGI |
| CFR Regulation Number | 884.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-22 |
| Decision Date | 2001-02-20 |