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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Manual, General Obstetric-Gynecologic
510(k) Number K000212
Device Name KSEA CHARDONNES MORCELLATION KNIFE
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Applicant Contact KEVIN KENNAN
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pointe
Culver City,  CA  90230 -7600
Correspondent Contact KEVIN KENNAN
Regulation Number884.4520
Classification Product Code
KOH  
Subsequent Product Code
GCJ  
Date Received01/24/2000
Decision Date 04/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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