The following data is part of a premarket notification filed by Medel S.p.a. with the FDA for Ag-plus, Model 91210.
| Device ID | K060404 |
| 510k Number | K060404 |
| Device Name: | AG-PLUS, MODEL 91210 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDEL S.P.A. 112 CAVISTON WAY Cary, NC 27519 |
| Contact | Terrence O'brien |
| Correspondent | Terrence O'brien MEDEL S.P.A. 112 CAVISTON WAY Cary, NC 27519 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-15 |
| Decision Date | 2006-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383730004044 | K060404 | 000 |
| 00383730002088 | K060404 | 000 |
| 00383730002071 | K060404 | 000 |
| 00383730002064 | K060404 | 000 |
| 00383730002057 | K060404 | 000 |
| 00383730002040 | K060404 | 000 |
| 00383730002033 | K060404 | 000 |
| 00383730002019 | K060404 | 000 |
| 00383730002002 | K060404 | 000 |
| 00383730001999 | K060404 | 000 |
| 00383730001982 | K060404 | 000 |
| 00383730001975 | K060404 | 000 |
| 00383730002095 | K060404 | 000 |
| 00383730002101 | K060404 | 000 |
| 00383730003979 | K060404 | 000 |
| 00383730002200 | K060404 | 000 |
| 00383730002194 | K060404 | 000 |
| 00383730002187 | K060404 | 000 |
| 00383730002170 | K060404 | 000 |
| 00383730002163 | K060404 | 000 |
| 00383730002156 | K060404 | 000 |
| 00383730002149 | K060404 | 000 |
| 00383730002132 | K060404 | 000 |
| 00383730002125 | K060404 | 000 |
| 00383730002118 | K060404 | 000 |
| 00383730001968 | K060404 | 000 |