ACCUPLACE (TM)

Guide, Needle, Surgical

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Accuplace (tm).

Pre-market Notification Details

Device IDK904172
510k NumberK904172
Device Name:ACCUPLACE (TM)
ClassificationGuide, Needle, Surgical
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactRoger Brink
CorrespondentRoger Brink
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeGDF  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-09-11
Decision Date1990-11-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.