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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 K131300
Device Name THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER
Applicant
ACCESS SCIENTIFIC, LLC
3910 Sorrento Valley Blvd Ste 200
San Diego,  CA  92121
Applicant Contact ALBERT MISAJON
Correspondent
ACCESS SCIENTIFIC, LLC
3910 Sorrento Valley Blvd Ste 200
San Diego,  CA  92121
Correspondent Contact ALBERT MISAJON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/07/2013
Decision Date 06/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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