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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fixation, Tracheal Tube
510(k) Number K964399
Device Name DALE ENDOTRACHEAL TUBE HOLDER 270/280
Applicant
Dale Medical Products, Inc.
7 Cross St.
P.O. Box 1556
Plainville,  MA  02762
Applicant Contact SHARON M STEEVES
Correspondent
Dale Medical Products, Inc.
7 Cross St.
P.O. Box 1556
Plainville,  MA  02762
Correspondent Contact SHARON M STEEVES
Regulation Number868.5770
Classification Product Code
CBH  
Date Received11/04/1996
Decision Date 01/28/1997
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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