The following data is part of a premarket notification filed by Skypro Medical Supplies Company with the FDA for Skypro, Sp01 Mask.
| Device ID | K152197 |
| 510k Number | K152197 |
| Device Name: | Skypro, SP01 Mask |
| Classification | Mask, Surgical |
| Applicant | Skypro Medical Supplies Company C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat 1-33 Cheung Tat Road, Tsing Yi, NT Hong Kong, CN |
| Contact | Cyrus Wong |
| Correspondent | Cyrus Wong Skypro Medical Supplies Company C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat Road, Tsing Yi, NT Hong Kong, CN |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-05 |
| Decision Date | 2016-08-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04897030537042 | K152197 | 000 |
| 04897030530982 | K152197 | 000 |