The following data is part of a premarket notification filed by Ferris Mfg. Corp. with the FDA for Bone Marrow Aspiration Kit.
Device ID | K781371 |
510k Number | K781371 |
Device Name: | BONE MARROW ASPIRATION KIT |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | FERRIS MFG. CORP. 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 | 1978-08-08 |
Decision Date | 1978-09-20 |