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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Assisted Reproduction
510(k) Number K003056
Device Name OVARIAL BIOPSY SET 324102-324108; OVARIAL BIOPSY SET 324200-324202; OVARIAL BIOPSY NEEDLE 32218
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 Number884.6100
Classification Product Code
MQE  
Date Received10/01/2000
Decision Date 12/13/2000
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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