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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K912498
Device Name THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR
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 Number884.1700
Classification Product Code
HIG  
Date Received06/05/1991
Decision Date 12/18/1991
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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