The following data is part of a premarket notification filed by Zhejiang Gongdong Medical Plastic Factory with the FDA for Gongdong Disposable Sharp Container.
| Device ID | K082042 |
| 510k Number | K082042 |
| Device Name: | GONGDONG DISPOSABLE SHARP CONTAINER |
| Classification | Container, Sharps |
| Applicant | ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY BEICHENG INDUSTRIAL AREA Huangyan, Taizhou, Zhejiang, CN 318020 |
| Contact | Weifeng Zhong |
| Correspondent | Weifeng Zhong ZHEJIANG GONGDONG MEDICAL PLASTIC FACTORY BEICHENG INDUSTRIAL AREA Huangyan, Taizhou, Zhejiang, CN 318020 |
| Product Code | MMK |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-18 |
| Decision Date | 2008-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784463131 | K082042 | 000 |
| 06947462492353 | K082042 | 000 |
| 16947462492381 | K082042 | 000 |
| 00811382013119 | K082042 | 000 |
| 00811382013447 | K082042 | 000 |
| 00811382013454 | K082042 | 000 |
| 00811382013461 | K082042 | 000 |
| 00811382018756 | K082042 | 000 |
| 00811382018770 | K082042 | 000 |
| 00811382019623 | K082042 | 000 |
| 00811382019630 | K082042 | 000 |
| 00811382019647 | K082042 | 000 |
| 00811382019654 | K082042 | 000 |
| 00811382019661 | K082042 | 000 |
| 06947462491547 | K082042 | 000 |