BONE MARROW BIOPSY DEVICE

Needle, Aspiration And Injection, Reusable

RADIATION DEVELOPMENT CO., INC.

The following data is part of a premarket notification filed by Radiation Development Co., Inc. with the FDA for Bone Marrow Biopsy Device.

Pre-market Notification Details

Device IDK772293
510k NumberK772293
Device Name:BONE MARROW BIOPSY DEVICE
ClassificationNeedle, Aspiration And Injection, Reusable
Applicant RADIATION DEVELOPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGDM  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-12-12
Decision Date1978-01-03

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