The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Prostate Locking Introducer Set.
| Device ID | K961377 |
| 510k Number | K961377 |
| Device Name: | MANAN PROSTATE LOCKING INTRODUCER SET |
| Classification | System, Applicator, Radionuclide, Manual |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Michael Plishka |
| Correspondent | Michael Plishka MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | IWJ |
| CFR Regulation Number | 892.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-10 |
| Decision Date | 1996-07-03 |