The following data is part of a premarket notification filed by Researched, Novel Medical Devices (rn/md) with the FDA for Bedside Caddy.
Device ID | K925234 |
510k Number | K925234 |
Device Name: | BEDSIDE CADDY |
Classification | Needle, Hypodermic, Single Lumen |
Applicant | RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD) 4480 SHERMAN OAKS CIRCLE Sherman Oaks, CA 91403 |
Contact | Annabelle D Tucker |
Correspondent | Annabelle D Tucker RESEARCHED, NOVEL MEDICAL DEVICES (RN/MD) 4480 SHERMAN OAKS CIRCLE Sherman Oaks, CA 91403 |
Product Code | FMI |
CFR Regulation Number | 880.5570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-16 |
Decision Date | 1993-11-19 |