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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K083218
Device Name TC ENDO PORT
Applicant
Transcardiac Therapeutics, Inc.
3355 Lenox Rd., NE
Suite 415
Atlanta,  GA  30326
Applicant Contact DAVID SMITH
Correspondent
Transcardiac Therapeutics, Inc.
3355 Lenox Rd., NE
Suite 415
Atlanta,  GA  30326
Correspondent Contact DAVID SMITH
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/31/2008
Decision Date 03/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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