The following data is part of a premarket notification filed by Specialty Packaging Producs, Inc. with the FDA for Oxygen Masks 81420, 81421, 81471 & 81461.
| Device ID | K913383 |
| 510k Number | K913383 |
| Device Name: | OXYGEN MASKS 81420, 81421, 81471 & 81461 |
| Classification | Mask, Oxygen |
| 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 | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-29 |
| Decision Date | 1991-10-18 |