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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
510(k) Number K944862
Device Name KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES
Applicant
KARL STORZ Endoscopy-America, Inc.
91 Carpenter Hill Rd.
Charlton,  MA  01507
Applicant Contact BETTY M JOHNSON
Correspondent
KARL STORZ Endoscopy-America, Inc.
91 Carpenter Hill Rd.
Charlton,  MA  01507
Correspondent Contact BETTY M JOHNSON
Regulation Number884.4160
Classification Product Code
KNF  
Subsequent Product Code
HET  
Date Received10/03/1994
Decision Date 02/09/1995
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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