FDA 510(k) Application Details - K172661

Device Classification Name Forceps, Surgical, Gynecological

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510(K) Number K172661
Device Name Forceps, Surgical, Gynecological
Applicant Fetzer Medical GmbH & Co. KG
Unter Buchsteig 5
Tuttlingen 78532 DE
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Contact Harald Jung
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Regulation Number 884.4530

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Classification Product Code HCZ
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Date Received 09/05/2017
Decision Date 05/08/2018
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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