FDA 510(k) Application Details - K970282

Device Classification Name Clamp, Circumcision

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510(K) Number K970282
Device Name Clamp, Circumcision
Applicant MEDLINE
ONE MEDLINE PLACE
MUNDLELEIN, IL 60060 US
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Regulation Number 884.4530

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Classification Product Code HFX
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Date Received 01/24/1997
Decision Date 03/06/1997
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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