The following data is part of a premarket notification filed by Sakura Seiki Co., Ltd. with the FDA for Sakura Steam Sterilizer Assr; -ao12, -a012w, -ao12p,-ao12pw / Skytron Integrity 270;steam Sterilizer,vp Steam Sterilizer.
| Device ID | K132439 |
| 510k Number | K132439 |
| Device Name: | SAKURA STEAM STERILIZER ASSR; -AO12, -A012W, -AO12P,-AO12PW / SKYTRON INTEGRITY 270;STEAM STERILIZER,VP STEAM STERILIZER |
| Classification | Sterilizer, Steam |
| Applicant | SAKURA SEIKI CO., LTD. 55 Northern Blvd Suite 200 Great Neck, NY 11021 |
| Contact | Maria F Griffin |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-08-05 |
| Decision Date | 2014-01-06 |
| Summary: | summary |