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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 K936231
Device Name THE KARL STORZ HAMOU ENDOMAT
Applicant
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Applicant Contact SUSIE S CHEN
Correspondent
KARL STORZ ENDOSCOPY
600 CORPORATE POINTE
CULVER CITY,  CA  90230 -7600
Correspondent Contact SUSIE S CHEN
Regulation Number884.1700
Classification Product Code
HIG  
Subsequent Product Code
HIF  
Date Received12/29/1993
Decision Date 01/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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