The following data is part of a premarket notification filed by Piper Medical Products with the FDA for Ezflow Continuous Nebulizer,model 1005.
| Device ID | K990384 |
| 510k Number | K990384 |
| Device Name: | EZFLOW CONTINUOUS NEBULIZER,MODEL 1005 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PIPER MEDICAL PRODUCTS 4007 SEAPORT BLVD. West Sacramento, CA 95691 |
| Contact | Samuel David Piper, Pe |
| Correspondent | Samuel David Piper, Pe PIPER MEDICAL PRODUCTS 4007 SEAPORT BLVD. West Sacramento, CA 95691 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-08 |
| Decision Date | 1999-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043320017 | K990384 | 000 |
| 30641043320000 | K990384 | 000 |
| 30641043320062 | K990384 | 000 |
| 30641043320055 | K990384 | 000 |
| 30641043320024 | K990384 | 000 |