The following data is part of a premarket notification filed by Cixi Leinuo Plastic Co. Ltd with the FDA for Sharps Container.
| Device ID | K101567 |
| 510k Number | K101567 |
| Device Name: | SHARPS CONTAINER |
| Classification | Container, Sharps |
| Applicant | CIXI LEINUO PLASTIC CO. LTD NO. 56 LUOMING SOUTH ROAD GUANHAIWEI TOWN , CIXI Ningbo, CN 315316 |
| Contact | Charles Mack |
| Correspondent | Charles Mack CIXI LEINUO PLASTIC CO. LTD NO. 56 LUOMING SOUTH ROAD GUANHAIWEI TOWN , CIXI Ningbo, CN 315316 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-04 |
| Decision Date | 2010-09-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B031SHARP4G1 | K101567 | 000 |
| 06973696790064 | K101567 | 000 |
| 06973696790071 | K101567 | 000 |
| 16973696790030 | K101567 | 000 |
| 16973696790016 | K101567 | 000 |
| 16973696790023 | K101567 | 000 |
| B031SHARP1G1 | K101567 | 000 |
| B031SHARP1Q1 | K101567 | 000 |
| B031SHARP2G1 | K101567 | 000 |
| 16973696790085 | K101567 | 000 |