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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K894586
Device Name DALE I.V. IDENTIFIER; PRODUCT #1125
Applicant
Dale Medical Products, Inc.
7 Cross St.
P.O. Box 1556
Plainville,  MA  02762
Applicant Contact DANIEL MCELANEY
Correspondent
Dale Medical Products, Inc.
7 Cross St.
P.O. Box 1556
Plainville,  MA  02762
Correspondent Contact DANIEL MCELANEY
Regulation Number880.5210
Classification Product Code
KMK  
Date Received07/24/1989
Decision Date 08/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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