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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 K990910
Device Name MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
Applicant
MTP MEDICAL TECHNICAL PROMOTION GMBH
P.O. BOX 1954
CULVER CITY,  CA  90232
Applicant Contact KEVIN KENNAN
Correspondent
MTP MEDICAL TECHNICAL PROMOTION GMBH
P.O. BOX 1954
CULVER CITY,  CA  90232
Correspondent Contact KEVIN KENNAN
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HET  
Date Received03/18/1999
Decision Date 06/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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