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 |