The following data is part of a premarket notification filed by Popper & Sons, Inc. with the FDA for J -jamshidi Type-bone Marrow Biopsy/aspi.
Device ID | K843830 |
510k Number | K843830 |
Device Name: | J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI |
Classification | Needle, Aspiration And Injection, Reusable |
Applicant | POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
Contact | Robert A Popper |
Correspondent | Robert A Popper POPPER & SONS, INC. 300 DENTON AVE. New Hyde Park, NY 11040 |
Product Code | GDM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-01 |
Decision Date | 1984-10-26 |