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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 K031974
Device Name ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
Applicant
ASAP ENDOSCOPIC PRODUCTS GMBH
KATHARINENSTR. 5
LUEBECK,  DE 23554
Applicant Contact MARTINA GUNDEROTH
Correspondent
ASAP ENDOSCOPIC PRODUCTS GMBH
KATHARINENSTR. 5
LUEBECK,  DE 23554
Correspondent Contact MARTINA GUNDEROTH
Regulation Number884.1690
Classification Product Code
HIH  
Subsequent Product Code
HET  
Date Received06/26/2003
Decision Date 09/29/2003
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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