The following data is part of a premarket notification filed by Winner Industries (shenzhen) Co., Ltd. with the FDA for Sterilization Pouch With Indicators.
| Device ID | K062704 |
| 510k Number | K062704 |
| Device Name: | STERILIZATION POUCH WITH INDICATORS |
| Classification | Wrap, Sterilization |
| Applicant | WINNER INDUSTRIES (SHENZHEN) CO., LTD. 1O37 WALNUT AVE. Pomona, CA 91766 |
| Contact | Ming Xie |
| Correspondent | Ming Xie WINNER INDUSTRIES (SHENZHEN) CO., LTD. 1O37 WALNUT AVE. Pomona, CA 91766 |
| Product Code | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-11 |
| Decision Date | 2007-06-08 |
| Summary: | summary |