The following data is part of a premarket notification filed by Smartpractice with the FDA for Allergeaze R Clear.
| Device ID | K103409 |
| 510k Number | K103409 |
| Device Name: | ALLERGEAZE R CLEAR |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | SMARTPRACTICE 3400 EAST MCDOWLL ROAD Phoenix, AZ 85008 |
| Contact | Kim Sullivan |
| Correspondent | Kim Sullivan SMARTPRACTICE 3400 EAST MCDOWLL ROAD Phoenix, AZ 85008 |
| Product Code | LDH |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-22 |
| Decision Date | 2011-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854498007112 | K103409 | 000 |