The following data is part of a premarket notification filed by Custom Medical Concepts, Inc. with the FDA for Spinal Cord Access Epidural Introducer System.
| Device ID | K904380 |
| 510k Number | K904380 |
| Device Name: | SPINAL CORD ACCESS EPIDURAL INTRODUCER SYSTEM |
| Classification | Needle, Spinal, Short Term |
| Applicant | CUSTOM MEDICAL CONCEPTS, INC. 26 HIGH ST. Chelmsford, MA 01824 |
| Contact | Edward Mcnamara |
| Correspondent | Edward Mcnamara CUSTOM MEDICAL CONCEPTS, INC. 26 HIGH ST. Chelmsford, MA 01824 |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-09-26 |
| Decision Date | 1993-04-08 |