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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 K951479
Device Name CATHETERIZATION INSERTION PACK UROLOGICAL, STERILE, DISPOSABLE
Applicant
Trinity Laboratories, Inc.
201 Kiley Dr.
P.O. Box 1818
Salisbury,  MD  21802
Applicant Contact B ASUMALLIK
Correspondent
Trinity Laboratories, Inc.
201 Kiley Dr.
P.O. Box 1818
Salisbury,  MD  21802
Correspondent Contact B ASUMALLIK
Regulation Number876.5130
Classification Product Code
FCM  
Subsequent Product Code
FCN  
Date Received03/30/1995
Decision Date 06/15/1995
Decision Substantially Equivalent (SESE)
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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