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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 K951178
Device Name UROLOGICAL CATHETER & ACCESSORIES
Applicant
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact DEBORAH F MANNING
Correspondent
Deroyal Industries, Inc.
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact DEBORAH F MANNING
Regulation Number876.5130
Classification Product Code
FCM  
Subsequent Product Code
KNX  
Date Received03/15/1995
Decision Date 04/21/1995
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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