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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
510(k) Number K952317
Device Name Kaplan-Simpson InfusaSleeve II Catheter
Applicant
Localmed, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Applicant Contact ELEANOR V CHIU
Correspondent
Localmed, Inc.
1820 Embarcadero Rd.
Palo Alto,  CA  94303
Correspondent Contact ELEANOR V CHIU
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Code
KRA  
Date Received05/17/1995
Decision Date 06/28/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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