The following data is part of a premarket notification filed by Acucera, Inc. with the FDA for Zirblank-ps And Zirblank-fs.
| Device ID | K070045 |
| 510k Number | K070045 |
| Device Name: | ZIRBLANK-PS AND ZIRBLANK-FS |
| Classification | Powder, Porcelain |
| Applicant | ACUCERA, INC. 539 JINBUL-LI JINJEOP, NAMYANGJU Gyeonggi, KR 472-861 |
| Contact | Kyung-bin Lee |
| Correspondent | Kyung-bin Lee ACUCERA, INC. 539 JINBUL-LI JINJEOP, NAMYANGJU Gyeonggi, KR 472-861 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-04 |
| Decision Date | 2007-03-26 |
| Summary: | summary |