The following data is part of a premarket notification filed by Jingzhou Haixin Green Cross Medical Products Co.,l with the FDA for Greencross Surgical Mask.
| Device ID | K123787 |
| 510k Number | K123787 |
| Device Name: | GREENCROSS SURGICAL MASK |
| Classification | Mask, Surgical |
| Applicant | JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,L 6 VANDERBLET ROAD Acton, MA 01720 |
| Contact | Xiangyang Song |
| Correspondent | Xiangyang Song JINGZHOU HAIXIN GREEN CROSS MEDICAL PRODUCTS CO.,L 6 VANDERBLET ROAD Acton, MA 01720 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-10 |
| Decision Date | 2013-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30851253007565 | K123787 | 000 |
| 00843792144275 | K123787 | 000 |
| 00818566019639 | K123787 | 000 |
| 20304040131712 | K123787 | 000 |
| 10850025200025 | K123787 | 000 |
| 00850025200011 | K123787 | 000 |
| 20304040132399 | K123787 | 000 |
| 06973141150009 | K123787 | 000 |
| 00811220033712 | K123787 | 000 |
| 30851253007916 | K123787 | 000 |
| 10818566013306 | K123787 | 000 |
| 10851253007424 | K123787 | 000 |
| 30851253007411 | K123787 | 000 |
| 10851253007400 | K123787 | 000 |
| 10854344002810 | K123787 | 000 |
| 10854344002803 | K123787 | 000 |
| 10818566017366 | K123787 | 000 |
| 10818566016642 | K123787 | 000 |
| 10818566016635 | K123787 | 000 |
| 00097604555517 | K123787 | 000 |