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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K904848
Device Name PORT-OF-ORGIN(TM) SINGLE-USE TROCAR AND SLEEVE
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 Number884.1720
Classification Product Code
HET  
Date Received10/26/1990
Decision Date 04/08/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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