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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
510(k) Number K950344
Device Name HORIZON FOLEY CATHETERIZATION TRAY WITHOUT CATHETER
Applicant
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Applicant Contact BEN WALTHALL
Correspondent
Acacia Laboratories, Inc.
1719 S. Grand Ave.
Santa Ana,  CA  92705
Correspondent Contact BEN WALTHALL
Regulation Number876.5130
Classification Product Code
FCM  
Date Received01/27/1995
Decision Date 03/24/1995
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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