The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Trek S Nebulizer Compressor.
| Device ID | K060357 |
| 510k Number | K060357 |
| Device Name: | TREK S NEBULIZER COMPRESSOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI INNOVATIVE MANUFACTURERS, INC. 2943 OAK LAKE BLVD. Midlothian, VA 23112 |
| Contact | Michael Judge |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229470151 | K060357 | 000 |
| 00744229470175 | K060357 | 000 |
| 00744229470212 | K060357 | 000 |
| 00744229470229 | K060357 | 000 |
| 00744229470182 | K060357 | 000 |
| 00744229470052 | K060357 | 000 |
| 00744229470236 | K060357 | 000 |
| 00744229470205 | K060357 | 000 |