The following data is part of a premarket notification filed by Specialty Packaging Producs, Inc. with the FDA for Non Rebreathing Mask.
| Device ID | K913164 |
| 510k Number | K913164 |
| Device Name: | NON REBREATHING MASK |
| Classification | Mask, Oxygen, Non-rebreathing |
| Applicant | SPECIALTY PACKAGING PRODUCS, INC. 19 LEIGH FISHER El Paso, TX 79906 |
| Contact | Edward F Valdez |
| Correspondent | Edward F Valdez SPECIALTY PACKAGING PRODUCS, INC. 19 LEIGH FISHER El Paso, TX 79906 |
| Product Code | KGB |
| CFR Regulation Number | 868.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-17 |
| Decision Date | 1992-01-15 |