The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Hyper Sal.
| Device ID | K070498 |
| 510k Number | K070498 |
| Device Name: | HYPER SAL |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI INNOVATIVE MANUFACTURERS, INC. 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PARI INNOVATIVE MANUFACTURERS, INC. 3460 POINTE CREEK CT. #102 Bonita Springs, FL 34134 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229307129 | K070498 | 000 |
| 00744229235125 | K070498 | 000 |
| 00744229207122 | K070498 | 000 |