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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 K100045
Device Name OCTO
Applicant
DALIM SURGNET CORPORATION
300 ATWOOD
PITTSBURGH,  PA  15213
Applicant Contact PETER CHUNG
Correspondent
DALIM SURGNET CORPORATION
300 ATWOOD
PITTSBURGH,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/08/2010
Decision Date 06/25/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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