The following data is part of a premarket notification filed by Oak Ridge Products, Llc with the FDA for Oak Ridge Products Sharp Container.
| Device ID | K130281 |
| 510k Number | K130281 |
| Device Name: | OAK RIDGE PRODUCTS SHARP CONTAINER |
| Classification | Container, Sharps |
| Applicant | OAK RIDGE PRODUCTS, LLC 4612 Century Ct Mchenry, IL 60050 |
| Contact | Tibor B 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 | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-02-05 |
| Decision Date | 2013-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889215309682 | K130281 | 000 |
| 10304040026509 | K130281 | 000 |
| 10304040018665 | K130281 | 000 |
| 10304040007416 | K130281 | 000 |
| 10304040007409 | K130281 | 000 |
| 10304040007393 | K130281 | 000 |
| 10304040007386 | K130281 | 000 |
| 10015482245044 | K130281 | 000 |
| 10015482245037 | K130281 | 000 |
| 10015482245020 | K130281 | 000 |
| 10304040040611 | K130281 | 000 |
| 10852482006417 | K130281 | 000 |
| 10852482006530 | K130281 | 000 |
| 10865273000099 | K130281 | 000 |
| 10865273000082 | K130281 | 000 |
| 10865273000068 | K130281 | 000 |
| 10865273000051 | K130281 | 000 |
| 10865273000044 | K130281 | 000 |
| 10865273000037 | K130281 | 000 |
| 10865273000020 | K130281 | 000 |
| 10865273000013 | K130281 | 000 |
| 10852482006578 | K130281 | 000 |
| 10015482245013 | K130281 | 000 |