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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Malecot
510(k) Number K954116
Device Name SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIP
Applicant
Technical Products, Inc.
2416 Park Central Blvd.
Decatur,  GA  30035
Applicant Contact NORBERT D THOMPSON
Correspondent
Technical Products, Inc.
2416 Park Central Blvd.
Decatur,  GA  30035
Correspondent Contact NORBERT D THOMPSON
Regulation Number876.5090
Classification Product Code
FEW  
Date Received07/20/1995
Decision Date 11/06/1995
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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