The following data is part of a premarket notification filed by Sakura Seiki Co., Ltd. with the FDA for Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 Sg Steam Sterilizer Sakura Steam Sterilizer Assv-ab09 Sakura.
| Device ID | K120149 |
| 510k Number | K120149 |
| Device Name: | SKYRON INTEGRITY 215 STEAM STERILIZER SKYTRON INTEGRITY 215 SG STEAM STERILIZER SAKURA STEAM STERILIZER ASSV-AB09 SAKURA |
| Classification | Sterilizer, Steam |
| Applicant | SAKURA SEIKI CO., LTD. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Correspondent | Dawn Tibodeau TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton, MN 55112 -1891 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-01-18 |
| Decision Date | 2012-05-08 |
| Summary: | summary |