The following data is part of a premarket notification filed by Westmed Intl. with the FDA for Boomerang Turbinate Glove And Septal Splint.
| Device ID | K925173 |
| 510k Number | K925173 |
| Device Name: | BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT |
| Classification | Splint, Intranasal Septal |
| 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 | LYA |
| CFR Regulation Number | 874.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-14 |
| Decision Date | 1993-01-15 |