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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 K860583
Device Name DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
Applicant
DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE,  MA  02762
Applicant Contact DANIEL W MCELANEY
Correspondent
DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE,  MA  02762
Correspondent Contact DANIEL W MCELANEY
Regulation Number868.5280
Classification Product Code
JAY  
Date Received02/18/1986
Decision Date 02/21/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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