The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Epidural Needle.
| Device ID | K980536 |
| 510k Number | K980536 |
| Device Name: | EPIDURAL NEEDLE |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Michael Plishka |
| Correspondent | Michael Plishka MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-11 |
| Decision Date | 1998-07-31 |