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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, Gynecologic (And Accessories)
510(k) Number K800668
Device Name CANNULA, W/SHARP OBTURATOR & VERESS NEED
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number884.1720
Classification Product Code
HET  
Date Received03/26/1980
Decision Date 05/08/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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