The following data is part of a premarket notification filed by Pari Holding Co. with the FDA for Pari-master Modification.
| Device ID | K935540 |
| 510k Number | K935540 |
| Device Name: | PARI-MASTER MODIFICATION |
| 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 | 1993-11-16 |
| Decision Date | 1995-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229850021 | K935540 | 000 |
| 00744229100560 | K935540 | 000 |
| 00744229100096 | K935540 | 000 |
| 00744229100133 | K935540 | 000 |
| 00744229100140 | K935540 | 000 |
| 00744229100157 | K935540 | 000 |
| 00744229100072 | K935540 | 000 |
| 00744229100089 | K935540 | 000 |
| 00744229100119 | K935540 | 000 |
| 00744229100034 | K935540 | 000 |
| 00744229100126 | K935540 | 000 |
| 00744229100102 | K935540 | 000 |
| 00744229100041 | K935540 | 000 |
| 00744229100720 | K935540 | 000 |