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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K946213
Device Name KSEA STEINER ELECTROMECHANIC MORCELLATORT
Applicant
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Applicant Contact MARIKA ANDERSON
Correspondent
KARL STORZ Endoscopy-America, Inc.
600 Corporate Pt.e
Culver City,  CA  90230
Correspondent Contact MARIKA ANDERSON
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received12/21/1994
Decision Date 01/27/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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