The following data is part of a premarket notification filed by Daum Corp. with the FDA for Daum Neurocut Neurobiopsyneedle.
Device ID | K990278 |
510k Number | K990278 |
Device Name: | DAUM NEUROCUT NEUROBIOPSYNEEDLE |
Classification | Instrument, Biopsy |
Applicant | DAUM CORP. P.O. BOX 4341 Crofton, MD 21114 |
Contact | E.j. Smith |
Correspondent | E.j. Smith DAUM CORP. 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 | 1999-01-28 |
Decision Date | 1999-03-30 |