The following data is part of a premarket notification filed by Airpharma, Llc with the FDA for E-z Spacer Mask (small).
| Device ID | K964956 |
| 510k Number | K964956 |
| Device Name: | E-Z SPACER MASK (SMALL) |
| Classification | Nebulizer, Medicinal, Non-ventilatory (atomizer) |
| Applicant | AIRPHARMA, LLC P.O. BOX 1142 Ramona, CA 92065 |
| Contact | Tom Evangelisti |
| Correspondent | Tom Evangelisti AIRPHARMA, LLC P.O. BOX 1142 Ramona, CA 92065 |
| Product Code | CCQ |
| CFR Regulation Number | 868.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-11 |
| Decision Date | 1997-04-23 |
| Summary: | summary |