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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 K935785
Device Name KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
1201 ROBERTS BLVD.
KENNESAW,  GA  30144
Applicant Contact SUSIE S CHEN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
1201 ROBERTS BLVD.
KENNESAW,  GA  30144
Correspondent Contact SUSIE S CHEN
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/06/1993
Decision Date 05/11/1994
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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