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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Embolectomy
510(k) Number K011783
Device Name MULTI-SNARE SET
Applicant
Pfm Produkte Fur Die Medizin AG
15 Cherokee St.
Trabuco Canyon,  CA  92679
Applicant Contact SALVADORE F PALOMARES
Correspondent
Pfm Produkte Fur Die Medizin AG
15 Cherokee St.
Trabuco Canyon,  CA  92679
Correspondent Contact SALVADORE F PALOMARES
Regulation Number870.5150
Classification Product Code
DXE  
Date Received06/07/2001
Decision Date 01/24/2002
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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