The following data is part of a premarket notification filed by Busse Hospital Disposables, Inc. with the FDA for Busse Epidural Catheter.
| Device ID | K070465 |
| 510k Number | K070465 |
| Device Name: | BUSSE EPIDURAL CATHETER |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Contact | Muhamad Ansari |
| Correspondent | Muhamad Ansari BUSSE HOSPITAL DISPOSABLES, INC. P.O. BOX 11067 Hauppauge, NY 11788 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-16 |
| Decision Date | 2007-07-19 |
| Summary: | summary |