FDA 510(k) Application Details - K960239

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

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510(K) Number K960239
Device Name Curette, Suction, Endometrial (And Accessories)
Applicant CUSTOM PACK RELIABILITY
4207 VINELAND ROAD, M-1
ORLANDO, FL 32811 US
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Contact RICHARD L ELLWOOD
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Regulation Number 884.1175

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Classification Product Code HHK
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Date Received 01/16/1996
Decision Date 05/23/1996
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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