The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Simon Breast Lesion Localization Needle.
| Device ID | K914941 |
| 510k Number | K914941 |
| Device Name: | SIMON BREAST LESION LOCALIZATION NEEDLE |
| Classification | Guide, Needle, Surgical |
| 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 | GDF |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-05-14 |