The following data is part of a premarket notification filed by Custom Medical Plastics, Inc. with the FDA for Sharps Container.
| Device ID | K970398 |
| 510k Number | K970398 |
| Device Name: | SHARPS CONTAINER |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CUSTOM MEDICAL PLASTICS, INC. 14315 C CIRCLE Omaha, NE 68144 |
| Contact | Daniel R Brown |
| Correspondent | Daniel R Brown CUSTOM MEDICAL PLASTICS, INC. 14315 C CIRCLE Omaha, NE 68144 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10797876146044 | K970398 | 000 |
| 20797876146140 | K970398 | 000 |
| 20797876146089 | K970398 | 000 |
| 10797876104341 | K970398 | 000 |
| 10797876102859 | K970398 | 000 |
| 40797876102362 | K970398 | 000 |