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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Culdoscope (And Accessories)
510(k) Number K033728
Device Name TRANSVAGINAL ENDOSCOPY SET
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
5TH FLOOR
CULVER CITY,  CA  90230 -7600
Applicant Contact YVONNE FERNANDEZ
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 CORPORATE POINTE
5TH FLOOR
CULVER CITY,  CA  90230 -7600
Correspondent Contact YVONNE FERNANDEZ
Regulation Number884.1640
Classification Product Code
HEW  
Date Received11/28/2003
Decision Date 02/27/2004
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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