The following data is part of a premarket notification filed by American White Cross, Inc. with the FDA for Air Max External Nasal Dilator Strip.
| Device ID | K962400 |
| 510k Number | K962400 |
| Device Name: | AIR MAX EXTERNAL NASAL DILATOR STRIP |
| Classification | Dilator, Nasal |
| Applicant | AMERICAN WHITE CROSS, INC. 349 LAKE RD. P.O. BOX 419 Dayville, CT 06241 |
| Contact | Paul B Callahan |
| Correspondent | Paul B Callahan AMERICAN WHITE CROSS, INC. 349 LAKE RD. P.O. BOX 419 Dayville, CT 06241 |
| Product Code | LWF |
| CFR Regulation Number | 874.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-21 |
| Decision Date | 1996-09-09 |