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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 K121748
Device Name THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL
Applicant
ACCESS SCIENTIFIC, INC.
12526 HIGH BLUFF DRIVE
SUITE 360
SAN DIEGO,  CA  92130
Applicant Contact ALBERT MISAJON
Correspondent
ACCESS SCIENTIFIC, INC.
12526 HIGH BLUFF DRIVE
SUITE 360
SAN DIEGO,  CA  92130
Correspondent Contact ALBERT MISAJON
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/14/2012
Decision Date 07/27/2012
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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