The following data is part of a premarket notification filed by Sturdy Industrial Co., Ltd with the FDA for Sturdy Autoclave Super Microm (models Sa-260ma And Sa-260ma-r).
| Device ID | K181993 |
| 510k Number | K181993 |
| Device Name: | STURDY Autoclave Super Microm (models SA-260MA And SA-260MA-R) |
| Classification | Sterilizer, Steam |
| Applicant | Sturdy Industrial Co., Ltd No. 168 Sec. 1, Zhongxing Road, Wugu District New Taipei City, TW 24872 |
| Contact | Wolfgang Huang |
| Correspondent | Wolfgang Huang Sturdy Industrial Co., Ltd No. 168 Sec. 1, Zhongxing Road, Wugu District New Taipei City, TW 24872 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-26 |
| Decision Date | 2019-11-01 |