The following data is part of a premarket notification filed by Popper & Sons, Inc. with the FDA for Gardner Type Bone Marrow Needle.
Device ID | K841301 |
510k Number | K841301 |
Device Name: | GARDNER TYPE BONE MARROW NEEDLE |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | POPPER & SONS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-30 |
Decision Date | 1984-06-05 |