The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Manan Super-core Biopsy Needle.
| Device ID | K950732 |
| 510k Number | K950732 |
| Device Name: | MANAN SUPER-CORE BIOPSY NEEDLE |
| Classification | Instrument, Biopsy |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Werner Mittermeier |
| Correspondent | Werner Mittermeier 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 | 1995-02-16 |
| Decision Date | 1995-03-02 |