CORE BIOPSY NEEDLE, CATALOG CODE #54006

Needle, Aspiration And Injection, Reusable

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Core Biopsy Needle, Catalog Code #54006.

Pre-market Notification Details

Device IDK891537
510k NumberK891537
Device Name:CORE BIOPSY NEEDLE, CATALOG CODE #54006
ClassificationNeedle, Aspiration And Injection, Reusable
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactRobert E Jankun
CorrespondentRobert E Jankun
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeGDM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-17
Decision Date1989-04-18

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