The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Safpace System.
| Device ID | K955829 |
| 510k Number | K955829 |
| Device Name: | SAFPACE SYSTEM |
| Classification | Electrode, Pacemaker, Temporary |
| Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Mark S Alsberge |
| Correspondent | Mark S Alsberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-26 |
| Decision Date | 1997-11-18 |
| Summary: | summary |