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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 K926480
Device Name LAPAROSCOPIC BALLOON RETRACTOR
Applicant
ORIGIN MEDSYSTEMS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Applicant Contact JILL SCHWEIGER
Correspondent
ORIGIN MEDSYSTEMS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Correspondent Contact JILL SCHWEIGER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/29/1992
Decision Date 10/15/1993
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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