The following data is part of a premarket notification filed by Safety-med Products, Inc. with the FDA for Protection Plus Earloop Procedure Mask.
| Device ID | K042654 |
| 510k Number | K042654 |
| Device Name: | PROTECTION PLUS EARLOOP PROCEDURE MASK |
| Classification | Mask, Surgical |
| Applicant | SAFETY-MED PRODUCTS, INC. 140 LONGMEADOW DRIVE Burlington, WI 53105 |
| Contact | Chris Wagner |
| Correspondent | Chris Wagner SAFETY-MED PRODUCTS, INC. 140 LONGMEADOW DRIVE Burlington, WI 53105 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-28 |
| Decision Date | 2004-12-17 |