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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K022318
Device Name VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
Applicant
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Applicant Contact DAGMAR MASER
Correspondent
VOMED VOLZER MEDIZINTECHNIK GMBH & CO.
AMSTEL 320-I
AMSTERDAM,  NL 1017AP
Correspondent Contact DAGMAR MASER
Regulation Number884.1730
Classification Product Code
HIF  
Date Received07/08/2002
Decision Date 09/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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