The following data is part of a premarket notification filed by Moller Medical Gmbh with the FDA for Möller Medical Biopsy Needles And Systems.
| Device ID | K162588 |
| 510k Number | K162588 |
| Device Name: | Möller Medical Biopsy Needles And Systems |
| Classification | Instrument, Biopsy |
| Applicant | Moller Medical GmbH Wasserkuppenstrabe 29-31 Fulda, DE 36043 |
| Contact | Christoph Traxler |
| Correspondent | Angela Kikowatz Moller Medical GmbH Wasserkuppenstrabe 29-31 Fulda, DE 36043 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-16 |
| Decision Date | 2017-06-19 |
| Summary: | summary |