The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Maxx 470 Core Biopsy Gun.
Device ID | K900082 |
510k Number | K900082 |
Device Name: | MAXX 470 CORE BIOPSY GUN |
Classification | Instrument, Biopsy |
Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Contact | Chet Vanhof |
Correspondent | Chet Vanhof DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Product Code | KNW |
CFR Regulation Number | 876.1075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-05 |
Decision Date | 1990-06-27 |