The following data is part of a premarket notification filed by Westmed Intl. with the FDA for Instant In-dwell Nasal Suct Tamp/allevia Nasal Tra.
| Device ID | K924944 |
| 510k Number | K924944 |
| Device Name: | INSTANT IN-DWELL NASAL SUCT TAMP/ALLEVIA NASAL TRA |
| Classification | Balloon, Epistaxis |
| Applicant | WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Contact | Lynn Hayse |
| Correspondent | Lynn Hayse WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Product Code | EMX |
| CFR Regulation Number | 874.4100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-09-30 |
| Decision Date | 1993-07-02 |