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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 K150525
Device Name SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E. GRAND AVE
EL SEGUNDO,  CA  90245
Applicant Contact SUSIE S. CHEN
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 E.GRAND AVE
EL SEGUNDO,  CA  90245
Correspondent Contact WINKIE S. WONG
Regulation Number884.1720
Classification Product Code
HET  
Subsequent Product Codes
FGB   GCJ  
Date Received03/02/2015
Decision Date 11/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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