The following data is part of a premarket notification filed by Oak Ridge Products, Llc with the FDA for Oak Ridge Products Multi-purpose Sharps Containers.
| Device ID | K141759 |
| 510k Number | K141759 |
| Device Name: | OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS |
| Classification | Container, Sharps |
| Applicant | OAK RIDGE PRODUCTS, LLC 4612 Century Ct Mchenry, IL 60050 |
| Contact | Conor J O'malley |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-07-01 |
| Decision Date | 2014-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889215309668 | K141759 | 000 |
| 10889215309637 | K141759 | 000 |
| 10865273000075 | K141759 | 000 |
| 10852482006554 | K141759 | 000 |
| 10852482006523 | K141759 | 000 |
| 00852482006403 | K141759 | 000 |
| 10304040026547 | K141759 | 000 |
| 10304040018672 | K141759 | 000 |
| 10015482243019 | K141759 | 000 |