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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 K873311
Device Name DALE I.V. CONNECT. LOCK & STABILIZER (STABILOK)220
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 Number880.5210
Classification Product Code
KMK  
Date Received08/17/1987
Decision Date 11/05/1987
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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