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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 K921103
Device Name RETRACTION INSTRUMENT
Applicant
ORIGIN MEDSYSTEMS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Applicant Contact ALBERT K CHIN
Correspondent
ORIGIN MEDSYSTEMS, INC.
1021 HOWARD AVE.
SAN CARLOS,  CA  94070
Correspondent Contact ALBERT K CHIN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/09/1992
Decision Date 09/09/1993
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
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