The following data is part of a premarket notification filed by Insert Molding Solutions, Inc with the FDA for Magnum Core Tissue Biopsy Needle Model Mn1820, Rp Cutting Needle Model Rp-1820, Mcn Core Tissue Biopsy Needle Model Mcn-.
| Device ID | K111529 |
| 510k Number | K111529 |
| Device Name: | MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL RP-1820, MCN CORE TISSUE BIOPSY NEEDLE MODEL MCN- |
| Classification | Instrument, Biopsy |
| Applicant | INSERT MOLDING SOLUTIONS, INC 4325 SETTINGDOWN CIRCLE SUITE 103 Cumming, GA 30028 |
| Contact | Paul Hendrixson |
| Correspondent | Paul Hendrixson INSERT MOLDING SOLUTIONS, INC 4325 SETTINGDOWN CIRCLE SUITE 103 Cumming, GA 30028 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-02 |
| Decision Date | 2011-07-29 |
| Summary: | summary |