The following data is part of a premarket notification filed by Biotronik, Inc. with the FDA for Modification To Biotronik's Sterilization Process.
| Device ID | K023803 |
| 510k Number | K023803 |
| Device Name: | MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS |
| Classification | Permanent Pacemaker Electrode |
| Applicant | BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Contact | Jon Brumbaugh |
| Correspondent | Jon Brumbaugh BIOTRONIK, INC. 6024 JEAN ROAD Lake Oswego, OR 97035 |
| Product Code | DTB |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-14 |
| Decision Date | 2002-12-11 |