510(k) K925173

BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT by Westmed Intl. — Product Code LYA

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