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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 K953561
Device Name PREPERITONEAL DISTENTION BALLOON SYSTEMS (MODIFICATION)
Applicant
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Applicant Contact RICHARD D RUSH
Correspondent
ORIGIN MEDSYSTEMS, INC.
135 CONSTITUTION DR.
MENLO PARK,  CA  94025
Correspondent Contact RICHARD D RUSH
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received07/14/1995
Decision Date 08/11/1995
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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