The following data is part of a premarket notification filed by Dey Laboratories, Inc. with the FDA for Nebu-sol Metered Dose Dispenser (tm).
| Device ID | K910239 |
| 510k Number | K910239 |
| Device Name: | NEBU-SOL METERED DOSE DISPENSER (TM) |
| Classification | Catheters, Suction, Tracheobronchial |
| Applicant | DEY LABORATORIES, INC. 2751 NAPA VALLEY CORPORATE DRIVE Napa, CA 94558 |
| Contact | Allan M Raff |
| Correspondent | Allan M Raff DEY LABORATORIES, INC. 2751 NAPA VALLEY CORPORATE DRIVE Napa, CA 94558 |
| Product Code | BSY |
| CFR Regulation Number | 868.6810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-22 |
| Decision Date | 1991-05-22 |