The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Bone Marrow Biopsy Needle.
| Device ID | K890925 |
| 510k Number | K890925 |
| Device Name: | MANAN BONE MARROW BIOPSY NEEDLE |
| Classification | Needle, Biopsy, Cardiovascular |
| 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 | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-24 |
| Decision Date | 1989-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20859013006097 | K890925 | 000 |
| 00859013006000 | K890925 | 000 |