The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Mammocore Biopsy Tray.
| Device ID | K943653 |
| 510k Number | K943653 |
| Device Name: | MAMMOCORE BIOPSY TRAY |
| Classification | Wrap, Sterilization |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Contact | Fred Mittermeier |
| Correspondent | Fred Mittermeier MANAN MEDICAL PRODUCTS, INC. 2200 CARLSON DR. Northbrook, IL 60062 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-28 |
| Decision Date | 1995-01-30 |