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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tunneled Catheter Remover
510(k) Number K063048
Device Name TRANS-CATHETER EXTRACTOR
Applicant
TRAN PA-C, INC.
3348 HERRINGRIDGE DR.
ORLANDO,  FL  32812
Applicant Contact TOM TRAN
Correspondent
TRAN PA-C, INC.
3348 HERRINGRIDGE DR.
ORLANDO,  FL  32812
Correspondent Contact TOM TRAN
Regulation Number880.5970
Classification Product Code
ODY  
Date Received10/04/2006
Decision Date 09/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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