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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pneumoperitoneum Needle
510(k) Number K904849
Device Name ORIGINEEDLE(TM)
Applicant
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Applicant Contact RICHARD RUSH
Correspondent
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Correspondent Contact RICHARD RUSH
Regulation Number876.1500
Classification Product Code
FHO  
Date Received10/26/1990
Decision Date 03/29/1991
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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