The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Mri Compatible Biopsy Needles.
| Device ID | K962977 |
| 510k Number | K962977 |
| Device Name: | MRI COMPATIBLE BIOPSY NEEDLES |
| Classification | Instrument, Biopsy |
| 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 | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-31 |
| Decision Date | 1997-10-09 |