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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K000646
Device Name DISPOSABLE INJECTOR OR DISPOSABLE SCLEROTHERAPY NEEDLE
Applicant
ENTERIC MEDICAL TECHNOLOGIES
1125 EAST HILLSDALE BLVD.
SUITE 106
FOSTER CITY,  CA  94404
Applicant Contact JILL M VISOR
Correspondent
ENTERIC MEDICAL TECHNOLOGIES
1125 EAST HILLSDALE BLVD.
SUITE 106
FOSTER CITY,  CA  94404
Correspondent Contact JILL M VISOR
Regulation Number876.1500
Classification Product Code
FBK  
Date Received02/25/2000
Decision Date 04/13/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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