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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Acoustic (For Audiometric Testing)
510(k) Number K823872
Device Name EMERGENCY TRACHEOSTOMY KIT
Applicant
Omnicon Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Omnicon Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number874.1060
Classification Product Code
EWC  
Date Received12/27/1982
Decision Date 01/21/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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