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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K935426
Device Name PREPERITONEAL DISTENTION BALLOON SYSTEM
Applicant
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Applicant Contact A. JILL SCHWEIGER
Correspondent
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Correspondent Contact A. JILL SCHWEIGER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received11/10/1993
Decision Date 01/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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