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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 K960214
Device Name CPR FOLEY CAHTETER KIT
Applicant
Custom Pack Reliability
4207 Vineland Rd., M-1
Orlando,  FL  32811
Applicant Contact RICHARD L ELLWOOD
Correspondent
Custom Pack Reliability
4207 Vineland Rd., M-1
Orlando,  FL  32811
Correspondent Contact RICHARD L ELLWOOD
Regulation Number876.5130
Classification Product Code
FCM  
Date Received01/16/1996
Decision Date 04/01/1996
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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