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 |