The following data is part of a premarket notification filed by Pari Respiratory Equipment, Inc. with the FDA for Pari Sinus.
| Device ID | K092560 |
| 510k Number | K092560 |
| Device Name: | PARI SINUS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Contact | Michael Judge |
| Correspondent | Michael Judge PARI RESPIRATORY EQUIPMENT, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-20 |
| Decision Date | 2010-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229100300 | K092560 | 000 |
| 00744229100287 | K092560 | 000 |
| 00744229100270 | K092560 | 000 |