The following data is part of a premarket notification filed by Sakura Seiki Co., Ltd. with the FDA for Sakura Steam Sterilizaer Model Assv-ah06; Sakura Steam Sterilizer Model Assv-ah06e; Skytron Integrity 175; Skytron Integ.
| Device ID | K122774 |
| 510k Number | K122774 |
| Device Name: | SAKURA STEAM STERILIZAER MODEL ASSV-AH06; SAKURA STEAM STERILIZER MODEL ASSV-AH06E; SKYTRON INTEGRITY 175; SKYTRON INTEG |
| Classification | Sterilizer, Steam |
| Applicant | SAKURA SEIKI CO., LTD. 46-1, SHINDEN Chikuma, Nagano, JP 387-0018 |
| Contact | Maria Griffin |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-09-10 |
| Decision Date | 2013-05-09 |
| Summary: | summary |