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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K000704
Device Name DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
Applicant
DMC MEDICAL LTD.
511 CATALINA RD.
FULLERTON,  CA  92835
Applicant Contact CHARMAINE HENDERSON
Correspondent
DMC MEDICAL LTD.
511 CATALINA RD.
FULLERTON,  CA  92835
Correspondent Contact CHARMAINE HENDERSON
Regulation Number878.4200
Classification Product Code
GBX  
Date Received03/02/2000
Decision Date 05/19/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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