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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K022257
Device Name VOMED PERIPHERAL VASCULAR ACCESSORIES, MODELS 1010 XXX-7090 XXX & 9006 XXX-9011 XXX
Applicant
Vomed Volzer Medizintechnik GmbH & Co.
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Applicant Contact DAGMAR MASER
Correspondent
Vomed Volzer Medizintechnik GmbH & Co.
Amstel 320-I
Amsterdam, Nh,  NL 1017AP
Correspondent Contact DAGMAR MASER
Regulation Number870.1390
Classification Product Code
DRC  
Subsequent Product Code
DTL  
Date Received07/12/2002
Decision Date 10/04/2002
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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