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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cannula, intrauterine insemination
510(k) Number K021438
Device Name INSEMINATION CATHETER, MODEL 320301
Applicant
LABOTECT LABOR-TECHNIK GOTTINGEN
WILLI-EICHLER-STR. 25
GOTTINGEN,  DE D-37079
Applicant Contact ANGELIKA ALBRECHT
Correspondent
LABOTECT LABOR-TECHNIK GOTTINGEN
WILLI-EICHLER-STR. 25
GOTTINGEN,  DE D-37079
Correspondent Contact ANGELIKA ALBRECHT
Regulation Number884.5250
Classification Product Code
MFD  
Date Received05/06/2002
Decision Date 07/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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