The following data is part of a premarket notification filed by Anhui Kangda Medical Products Co., Ltd. with the FDA for Baixin Disposable Syringe, Multiple Sizes.
| Device ID | K083686 |
| 510k Number | K083686 |
| Device Name: | BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES |
| Classification | Syringe, Piston |
| Applicant | ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. 1707 YINQIAO BLDG. 58 JINXIN RD., JINQIAO Pudong, Shanghai, CN 201206 |
| Contact | Bian Wei Qiang |
| Correspondent | Bian Wei Qiang ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. 1707 YINQIAO BLDG. 58 JINXIN RD., JINQIAO Pudong, Shanghai, CN 201206 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10819667020156 | K083686 | 000 |
| 16936018500113 | K083686 | 000 |
| 16936018500083 | K083686 | 000 |
| 16936018500052 | K083686 | 000 |
| 16936018500021 | K083686 | 000 |
| 06936018500413 | K083686 | 000 |
| 06936018500383 | K083686 | 000 |
| 06936018500352 | K083686 | 000 |
| 06936018500321 | K083686 | 000 |
| 06936018500291 | K083686 | 000 |
| 06936018500260 | K083686 | 000 |
| 06936018500239 | K083686 | 000 |
| 06936018500208 | K083686 | 000 |
| 06936018500178 | K083686 | 000 |
| 06936018500147 | K083686 | 000 |
| 06936018500116 | K083686 | 000 |
| 06936018500086 | K083686 | 000 |
| 16936018500144 | K083686 | 000 |
| 16936018500175 | K083686 | 000 |
| 10819667020149 | K083686 | 000 |
| 10819667020125 | K083686 | 000 |
| 20850789007202 | K083686 | 000 |
| 20850789007196 | K083686 | 000 |
| 10850789007335 | K083686 | 000 |
| 10850789007328 | K083686 | 000 |
| 10850789007205 | K083686 | 000 |
| 10850789007199 | K083686 | 000 |
| 10850789007137 | K083686 | 000 |
| 20853620005467 | K083686 | 000 |
| 20853620005450 | K083686 | 000 |
| 20853620005238 | K083686 | 000 |
| 06936018500000 | K083686 | 000 |
| 16936018500267 | K083686 | 000 |
| 16936018500236 | K083686 | 000 |
| 16936018500205 | K083686 | 000 |
| 06936018500888 | K083686 | 000 |