The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Prostate Seeding Needle.
| Device ID | K902622 |
| 510k Number | K902622 |
| Device Name: | MANAN PROSTATE SEEDING NEEDLE |
| Classification | Source, Brachytherapy, Radionuclide |
| 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 | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-14 |
| Decision Date | 1990-08-10 |