The following data is part of a premarket notification filed by Dey Laboratories, Inc. with the FDA for Dey Vial Sodium Chloride 3%.
| Device ID | K972778 |
| 510k Number | K972778 |
| Device Name: | DEY VIAL SODIUM CHLORIDE 3% |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | DEY LABORATORIES, INC. 2751 NAPA VALLEY CORPORATE DRIVE Napa, CA 94558 |
| Contact | Allan S Kaplan |
| Correspondent | Allan S Kaplan DEY LABORATORIES, INC. 2751 NAPA VALLEY CORPORATE DRIVE Napa, CA 94558 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-25 |
| Decision Date | 1997-10-08 |
| Summary: | summary |