The following data is part of a premarket notification filed by B-k Medical Aps with the FDA for Biopsy Guide Kit For 8808 And Biplane, Endfire And Dual Biopsy Guides For 8818.
| Device ID | K081323 |
| 510k Number | K081323 |
| Device Name: | BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818 |
| Classification | Biopsy Needle |
| Applicant | B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Contact | Jens Rasmussen |
| Correspondent | Jens Rasmussen B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-12 |
| Decision Date | 2008-07-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704916000790 | K081323 | 000 |
| 05704916000776 | K081323 | 000 |
| 05704916000752 | K081323 | 000 |
| 05704916000738 | K081323 | 000 |
| 05704916000714 | K081323 | 000 |
| 05704916000691 | K081323 | 000 |