The following data is part of a premarket notification filed by Medsource International, Llc with the FDA for Medsource Sharps Dart.
| Device ID | K150333 |
| 510k Number | K150333 |
| Device Name: | MedSource Sharps Dart |
| Classification | Container, Sharps |
| Applicant | MedSource International, LLC 401 Norex Drive Chaska, MN 55318 |
| Contact | Laura Riggen |
| Correspondent | Howard T Cooper EQACT INC. 11715 Fox Road Indianapolis, IN 46236 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-10 |
| Decision Date | 2015-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816703021392 | K150333 | 000 |
| 00815277027311 | K150333 | 000 |
| 00817617023526 | K150333 | 000 |