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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Tracheal Tube
510(k) Number K843490
Device Name TUBE-STAT
Applicant
Concept, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Concept, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5790
Classification Product Code
BSR  
Date Received09/06/1984
Decision Date 10/04/1984
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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