The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Accuplace (tm).
Device ID | K904172 |
510k Number | K904172 |
Device Name: | ACCUPLACE (TM) |
Classification | Guide, Needle, Surgical |
Applicant | DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Contact | Roger Brink |
Correspondent | Roger Brink DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids, MI 49501 |
Product Code | GDF |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-11 |
Decision Date | 1990-11-21 |