The following data is part of a premarket notification filed by Clevex Inc. with the FDA for Exiclip Excs-m.
| Device ID | K070836 |
| 510k Number | K070836 |
| Device Name: | EXICLIP EXCS-M |
| Classification | Device, Percutaneous, Biopsy |
| Applicant | CLEVEX INC. 9996 CARROUSEL CT Loveland, OH 45140 |
| Contact | Lena Sattler |
| Correspondent | Lena Sattler CLEVEX INC. 9996 CARROUSEL CT Loveland, OH 45140 |
| Product Code | MJG |
| Subsequent Product Code | FZQ |
| Subsequent Product Code | GDO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-27 |
| Decision Date | 2007-04-20 |
| Summary: | summary |