510(k) K925173
K925173 is an FDA 510(k) premarket notification submitted by Westmed Intl. for the device "BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT". The FDA issued a decision of Substantially Equivalent on January 15, 1993. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Westmed Intl. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 1993
- Date Received
- October 14, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Splint, Intranasal Septal
- Device Class
- Class I
- Regulation Number
- 874.4780
- Review Panel
- EN
- Submission Type