The following data is part of a premarket notification filed by Perfaction, Inc. with the FDA for Airgent, Model Ag7000010.
| Device ID | K082138 |
| 510k Number | K082138 |
| Device Name: | AIRGENT, MODEL AG7000010 |
| Classification | Injector, Fluid, Non-electrically Powered |
| Applicant | PERFACTION, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Contact | Jonathan S Kahan |
| Correspondent | Jonathan S Kahan PERFACTION, INC. 555 THIRTEENTH STREET, NW Washington, DC 20004 |
| Product Code | KZE |
| CFR Regulation Number | 880.5430 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-29 |
| Decision Date | 2009-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290017151007 | K082138 | 000 |