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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 K930663
Device Name IV COMFORT PAD
Applicant
D.J. Scott Mfg., Inc.
23102 Terra Dr.
Laguna Hills,  CA  92653
Applicant Contact JOHN R SMITH
Correspondent
D.J. Scott Mfg., Inc.
23102 Terra Dr.
Laguna Hills,  CA  92653
Correspondent Contact JOHN R SMITH
Regulation Number880.5210
Classification Product Code
KMK  
Date Received02/09/1993
Decision Date 09/30/1993
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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