The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Daum Biopsyneedle.
Device ID | K961185 |
510k Number | K961185 |
Device Name: | DAUM BIOPSYNEEDLE |
Classification | Biopsy Needle |
Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Contact | Frank Ferguson |
Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
Product Code | FCG |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-03-26 |
Decision Date | 1996-04-30 |
Summary: | summary |