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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K022823
Device Name VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520
Applicant
Geister Medizin Technik GmbH
152b Bridge St.
Hot Springs,  NC  28743
Applicant Contact DAGMAR MASER
Correspondent
Geister Medizin Technik GmbH
152b Bridge St.
Hot Springs,  NC  28743
Correspondent Contact DAGMAR MASER
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received08/26/2002
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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