FDA 510(k) Application Details - K974819

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

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510(K) Number K974819
Device Name Curette, Suction, Endometrial (And Accessories)
Applicant SELECT MEDICAL SYSTEMS, INC.
2 WINTERSPORT LN.
WILLISTON, VT 05495 US
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Contact MONIQUE GIRARD
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Regulation Number 884.1175

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Classification Product Code HHK
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Date Received 12/23/1997
Decision Date 03/23/1998
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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