FDA 510(k)

BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT

K-Number: K925173 · 1993-01-15

Decision Date1993-01-15

Product CodeLYA

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT is the device name listed in this FDA 510(k) record. The listed applicant is Westmed Intl.. It received FDA 510(k) clearance on 1993-01-15 under 510(k) number K925173. The device is classified under product code LYA. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT?

BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Westmed Intl.. The 510(k) number is K925173.

When did BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT receive FDA 510(k) clearance?

BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT received FDA 510(k) clearance on 1993-01-15, under 510(k) number K925173.

Who is the listed applicant for BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT?

The FDA 510(k) record lists Westmed Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT?

The FDA product code for BOOMERANG TURBINATE GLOVE AND SEPTAL SPLINT is LYA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.