The following data is part of a premarket notification filed by Covidien with the FDA for Air Assisted Sprayer, Models: Airsprayus01 And Airsprayus.
| Device ID | K082322 |
| 510k Number | K082322 |
| Device Name: | AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | COVIDIEN 101A FIRST AVE Waltham, MA 02451 |
| Contact | Virginia Vetter |
| Correspondent | Virginia Vetter COVIDIEN 101A FIRST AVE Waltham, MA 02451 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-13 |
| Decision Date | 2008-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780023388 | K082322 | 000 |
| 10884521057920 | K082322 | 000 |