The following data is part of a premarket notification filed by Dey Laboratories, Inc. with the FDA for Dey-vial Sodium Chloride Solution, Usp, Sterile.
| Device ID | K880411 |
| 510k Number | K880411 |
| Device Name: | DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DEY LABORATORIES, INC. 1011 DETROIT AVE. Concord, CA 94518 |
| Contact | Raff, Phd |
| Correspondent | Raff, Phd DEY LABORATORIES, INC. 1011 DETROIT AVE. Concord, CA 94518 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-01 |
| Decision Date | 1988-02-29 |