The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Core Biopsy Needle, Catalog Code #54006.
Device ID | K891537 |
510k Number | K891537 |
Device Name: | CORE BIOPSY NEEDLE, CATALOG CODE #54006 |
Classification | Needle, Aspiration And Injection, Reusable |
Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Contact | Robert E Jankun |
Correspondent | Robert E Jankun DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Product Code | GDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-03-17 |
Decision Date | 1989-04-18 |