The following data is part of a premarket notification filed by Spintech Llc with the FDA for Spin Care Disposable Protective Mask.
| Device ID | K201624 |
| 510k Number | K201624 |
| Device Name: | Spin Care Disposable Protective Mask |
| Classification | Mask, Surgical |
| Applicant | SpinTech LLC 1920 Flintstone Drive Statesville, NC 28677 |
| Contact | Jim Jean |
| Correspondent | W. Victoria Rogers Rogers Consulting 11110 Arranmore Cove Roanoke, IN 46783 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-15 |
| Decision Date | 2021-03-18 |