The following data is part of a premarket notification filed by Researched, Novel Medical Devices (rn/md) with the FDA for One Step Specimen Collector/transport Container.
| Device ID | K942753 |
| 510k Number | K942753 |
| Device Name: | ONE STEP SPECIMEN COLLECTOR/TRANSPORT CONTAINER |
| Classification | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| 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 | EYZ |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-10 |
| Decision Date | 1994-11-02 |