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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps, Tube Introduction
510(k) Number K820451
Device Name INTRODUCER FOR ENDOTRACHEAL TUBE
Applicant
Imed Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Imed Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5780
Classification Product Code
BWB  
Date Received02/18/1982
Decision Date 03/26/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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