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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 K913816
Device Name ORIGINEEDLE, MODIFICATION
Applicant
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Applicant Contact FREDERIC H MOLL
Correspondent
Origin Medsystems, Inc.
1900 S. Norfolk St.,
Suite 312
San Mateo,  CA  94403
Correspondent Contact FREDERIC H MOLL
Regulation Number876.1500
Classification Product Code
FHO  
Date Received08/26/1991
Decision Date 11/08/1991
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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