The following data is part of a premarket notification filed by Kuwotech Co., Ltd with the FDA for Zirmon Series.
| Device ID | K131117 |
| 510k Number | K131117 |
| Device Name: | ZIRMON SERIES |
| Classification | Powder, Porcelain |
| Applicant | KUWOTECH CO., LTD 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung KUWOTECH CO., LTD 1515 E KATELLA AVE UNIT 2115 Anaheim, CA 92805 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-22 |
| Decision Date | 2013-07-26 |
| Summary: | summary |