The following data is part of a premarket notification filed by Puravita M, Llc with the FDA for Puravita Medical Fold Flat Surgical Mask.
| Device ID | K212740 |
| 510k Number | K212740 |
| Device Name: | Puravita Medical Fold Flat Surgical Mask |
| Classification | Mask, Surgical |
| Applicant | Puravita M, LLC 1287 W 300S Lindon, UT 84042 |
| Contact | Jefferson Nemelka |
| Correspondent | Rhonda Alexander IUVO Consulting, LLC P.O. Box 56436 Virginia Beach, VA 23456 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-30 |
| Decision Date | 2021-12-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850022550218 | K212740 | 000 |