The following data is part of a premarket notification filed by Daum Gmbh with the FDA for Daum Neurogate Trocar.
Device ID | K990782 |
510k Number | K990782 |
Device Name: | DAUM NEUROGATE TROCAR |
Classification | Instrument, Biopsy |
Applicant | DAUM GMBH P.O. BOX 4341 Crofton, MD 21114 |
Contact | E.j. Smith |
Correspondent | E.j. Smith DAUM GMBH P.O. BOX 4341 Crofton, MD 21114 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-03-09 |
Decision Date | 1999-04-28 |