The following data is part of a premarket notification filed by Specialty Packaging Producs, Inc. with the FDA for Non Rebreathing Valve.
Device ID | K913163 |
510k Number | K913163 |
Device Name: | NON REBREATHING VALVE |
Classification | Valve, 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 | CBP |
CFR Regulation Number | 868.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-07-17 |
Decision Date | 1992-02-03 |