The following data is part of a premarket notification filed by Oak Ridge Products, Llc with the FDA for Oak Ridge Products Sharps Containers.
| Device ID | K161180 |
| 510k Number | K161180 |
| Device Name: | Oak Ridge Products Sharps Containers |
| Classification | Container, Sharps |
| Applicant | OAK RIDGE PRODUCTS, LLC 4612 Century Ct Mchenry, IL 60050 |
| Contact | Tibor Kovari |
| 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 | 2016-04-27 |
| Decision Date | 2016-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889215309675 | K161180 | 000 |
| 10304040026523 | K161180 | 000 |
| 10304040026530 | K161180 | 000 |
| 10852482006509 | K161180 | 000 |
| 10852482006516 | K161180 | 000 |
| 10852482006561 | K161180 | 000 |
| 10852482006585 | K161180 | 000 |
| 10852482006592 | K161180 | 000 |
| 10865273000006 | K161180 | 000 |
| 10889215309644 | K161180 | 000 |
| 10889215309651 | K161180 | 000 |
| 10304040026516 | K161180 | 000 |