The following data is part of a premarket notification filed by Safesource Direct, Llc with the FDA for Procedure Mask With Ear Loops And Surgical Mask With Ties.
| Device ID | K221134 |
| 510k Number | K221134 |
| Device Name: | Procedure Mask With Ear Loops And Surgical Mask With Ties |
| Classification | Mask, Surgical |
| Applicant | SafeSource Direct, LLC 200 St Nazaire Rd. Broussard, LA 70518 |
| Contact | Robbie Wicks |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-04-19 |
| Decision Date | 2022-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850037747153 | K221134 | 000 |
| 00850037747146 | K221134 | 000 |
| 00850037747139 | K221134 | 000 |
| 00850037747122 | K221134 | 000 |