The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Monoject Bone Marrow Biopsy Trays.
Device ID | K945109 |
510k Number | K945109 |
Device Name: | MONOJECT BONE MARROW BIOPSY TRAYS |
Classification | Needle, Aspiration And Injection, Disposable |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | Frank J Fucile |
Correspondent | Frank J Fucile SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Product Code | GAA |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-18 |
Decision Date | 1994-11-14 |