The following data is part of a premarket notification filed by Dormer Laboratories, Inc. with the FDA for Iq Chambers.
| Device ID | K992553 |
| 510k Number | K992553 |
| Device Name: | IQ CHAMBERS |
| Classification | System, Delivery, Allergen And Vaccine |
| Applicant | DORMER LABORATORIES, INC. 2000 M. ST., N.W., 7TH FLOOR Washington, DC 20036 -3307 |
| Contact | Daniel Manelli |
| Correspondent | Daniel Manelli DORMER LABORATORIES, INC. 2000 M. ST., N.W., 7TH FLOOR Washington, DC 20036 -3307 |
| 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 | 1999-07-30 |
| Decision Date | 2000-04-12 |
| Summary: | summary |