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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hysteroscope (And Accessories)
510(k) Number K882270
Device Name MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES
Applicant
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Applicant Contact ROBERT R GIORGINI
Correspondent
KARL STORZ Endoscopy-America, Inc.
10111 W. Jefferson Blvd.
Culver City,  CA  90232
Correspondent Contact ROBERT R GIORGINI
Regulation Number884.1690
Classification Product Code
HIH  
Date Received05/31/1988
Decision Date 10/20/1989
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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