The following data is part of a premarket notification filed by B. Braun Medical, Inc. with the FDA for Soft Tip Epidural Catheter Kit.
| Device ID | K971233 |
| 510k Number | K971233 |
| Device Name: | SOFT TIP EPIDURAL CATHETER KIT |
| Classification | Anesthesia Conduction Kit |
| Applicant | B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Contact | Mark S Alberge |
| Correspondent | Mark S Alberge B. BRAUN MEDICAL, INC. 824 TWELFTH AVE. Bethlehem, PA 18018 |
| Product Code | CAZ |
| CFR Regulation Number | 868.5140 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-10-17 |
| Summary: | summary |