The following data is part of a premarket notification filed by Pari Innovative Manufacturers, Inc. with the FDA for Lc Sprint Star.
| Device ID | K062158 |
| 510k Number | K062158 |
| Device Name: | LC SPRINT STAR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PARI INNOVATIVE MANUFACTURERS, INC. 2943 OAKLAKE BLVD. Midlothian, VA 23112 |
| Contact | Mike Judge |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-28 |
| Decision Date | 2006-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00744229230205 | K062158 | 000 |