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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Support, Breathing Tube
510(k) Number K840844
Device Name ENDO-SECURE
Applicant
Exidyne, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Exidyne, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number868.5280
Classification Product Code
JAY  
Date Received02/24/1984
Decision Date 03/16/1984
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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