The following data is part of a premarket notification filed by Pari Holding Co. with the FDA for Lc Star Reusable Nebulizer 22f50 And Lc Star Disposable Nebulizer 22f70.
| Device ID | K963924 |
| 510k Number | K963924 |
| Device Name: | LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI HOLDING CO. 7493 WHITEPINE RD. Richmond, VA 23237 |
| Contact | Miguel A Arrizon |
| Correspondent | Miguel A Arrizon PARI HOLDING CO. 7493 WHITEPINE RD. Richmond, VA 23237 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-30 |
| Decision Date | 1996-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229100058 | K963924 | 000 |
| 00744229220237 | K963924 | 000 |
| 00744229220213 | K963924 | 000 |
| 00744229220190 | K963924 | 000 |