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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 K854040
Device Name I.V. DRESSING
Applicant
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Applicant Contact WILLIAM ABRAHAM
Correspondent
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Correspondent Contact WILLIAM ABRAHAM
Regulation Number880.5210
Classification Product Code
KMK  
Date Received10/02/1985
Decision Date 01/09/1986
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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