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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K130687
Device Name 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER
Applicant
MEDICAL COMPONENTS INC
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Applicant Contact JESSICA LEO
Correspondent
MEDICAL COMPONENTS INC
1499 DELP DRIVE
HARLEYSVILLE,  PA  19438
Correspondent Contact JESSICA LEO
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/13/2013
Decision Date 08/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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