The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Bone Biopsy Needle.
| Device ID | K902177 |
| 510k Number | K902177 |
| Device Name: | MANAN BONE BIOPSY NEEDLE |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Manfred Mittermeier |
| Correspondent | Manfred Mittermeier MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-15 |
| Decision Date | 1990-09-05 |