The following data is part of a premarket notification filed by Galemed Corp. with the FDA for Galemed Neb-easy Nebulizer.
| Device ID | K021742 |
| 510k Number | K021742 |
| Device Name: | GALEMED NEB-EASY NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | GALEMED CORP. 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks GALEMED CORP. 29201 VIA NORTE Temecula, CA 92591 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-28 |
| Decision Date | 2002-10-25 |
| Summary: | summary |