The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Prostatic Biopsy Needle.
| Device ID | K895897 |
| 510k Number | K895897 |
| Device Name: | MANAN PROSTATIC BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| 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 | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-06 |
| Decision Date | 1989-10-18 |