MAXX 470 CORE BIOPSY GUN

Instrument, Biopsy

DLP, INC.

The following data is part of a premarket notification filed by Dlp, Inc. with the FDA for Maxx 470 Core Biopsy Gun.

Pre-market Notification Details

Device IDK900082
510k NumberK900082
Device Name:MAXX 470 CORE BIOPSY GUN
ClassificationInstrument, Biopsy
Applicant DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
ContactChet Vanhof
CorrespondentChet Vanhof
DLP, INC. P.O.BOX 409 620 WATSONS S.W. Grand Rapids,  MI  49501
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-05
Decision Date1990-06-27

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