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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K850133
Device Name VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR.
Applicant
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Applicant Contact WILLIAM W ABRAHAM
Correspondent
Consolidated Medical Equipment, Inc.
310 Broad St.
Utica,  NY  13501
Correspondent Contact WILLIAM W ABRAHAM
Regulation Number880.5240
Classification Product Code
KGX  
Date Received01/14/1985
Decision Date 02/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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