FDA 510(k) Application Details - K051294

Device Classification Name Curette, Suction, Endometrial (And Accessories)

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510(K) Number K051294
Device Name Curette, Suction, Endometrial (And Accessories)
Applicant FEMSPEC L.L.C.
1530 HOLCOMB STREET
PORT TOWNSEND, WA 98368 US
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Contact CARL YOUNGMANN
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Regulation Number 884.1175

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Classification Product Code HHK
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Date Received 05/18/2005
Decision Date 12/21/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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