The following data is part of a premarket notification filed by Manan Medical Products, Inc. with the FDA for Mri Chiba,spinal,breast Localization,automatic Cutting Needles.
| Device ID | K980211 |
| 510k Number | K980211 |
| Device Name: | MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES |
| Classification | Instrument, Biopsy |
| Applicant | MANAN MEDICAL PRODUCTS, INC. 4445 S.W. 35TH TERRACE SUITE 310 Gainsville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Karl Swartz MANAN MEDICAL PRODUCTS, INC. 4445 S.W. 35TH TERRACE SUITE 310 Gainsville, FL 32608 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-21 |
| Decision Date | 1998-02-06 |
| Summary: | summary |