The following data is part of a premarket notification filed by Protectaide, Inc. with the FDA for Protectaide Personal Protection Pack No. 18000.
| Device ID | K942474 |
| 510k Number | K942474 |
| Device Name: | PROTECTAIDE PERSONAL PROTECTION PACK NO. 18000 |
| Classification | Mask, Surgical |
| Applicant | PROTECTAIDE, INC. 605 WHITE HILLS DR. Rockwall, TX 75087 |
| Contact | Jan Davis |
| Correspondent | Jan Davis PROTECTAIDE, INC. 605 WHITE HILLS DR. Rockwall, TX 75087 |
| Product Code | FXX |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-25 |
| Decision Date | 1994-10-18 |