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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular occluding, temporary
510(k) Number K051137
Device Name TECHDEVICE OCCLUSION BALLOON CATHETER
Applicant
TECHDEVICE CORPORATION
650 PLEASANT ST.
WATERTOWN,  MA  02472
Applicant Contact LEIGH HAYWARD
Correspondent
TECHDEVICE CORPORATION
650 PLEASANT ST.
WATERTOWN,  MA  02472
Correspondent Contact LEIGH HAYWARD
Regulation Number870.4450
Classification Product Code
MJN  
Date Received05/04/2005
Decision Date 02/24/2006
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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