The following data is part of a premarket notification filed by Dey Laboratories, Inc. with the FDA for Dey-pak Purified Water, Usp, Sterile.
| Device ID | K875011 |
| 510k Number | K875011 |
| Device Name: | DEY-PAK PURIFIED WATER, USP, STERILE |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | DEY LABORATORIES, INC. 1011 DETROIT AVE. Concord, CA 94518 |
| Contact | Raff, Ph.d. |
| Correspondent | Raff, Ph.d. DEY LABORATORIES, INC. 1011 DETROIT AVE. Concord, CA 94518 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-04 |
| Decision Date | 1988-01-22 |