The following data is part of a premarket notification filed by Piper Medical Products with the FDA for Ezflow Max, Model 1007.
| Device ID | K993558 |
| 510k Number | K993558 |
| Device Name: | EZFLOW MAX, MODEL 1007 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | PIPER MEDICAL PRODUCTS 4007 SEAPORT BLVD. West Sacramento, CA 95691 |
| Contact | Samuel David Piper |
| Correspondent | Samuel David Piper 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 | 1999-10-20 |
| Decision Date | 1999-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043320093 | K993558 | 000 |
| 30641043320048 | K993558 | 000 |
| 30641043320031 | K993558 | 000 |