The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Lifeshield Blood Collection Device.
Device ID | K933751 |
510k Number | K933751 |
Device Name: | LIFESHIELD BLOOD COLLECTION DEVICE |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Contact | K. Michael Kroehnke |
Correspondent | K. Michael Kroehnke SHERWOOD MEDICAL CO. 1915 OLIVE ST. St. Louis, MO 63103 -1625 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-03 |
Decision Date | 1994-02-14 |