FDA 510(k) Application Details - K021876

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

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510(K) Number K021876
Device Name Curette, Suction, Endometrial (And Accessories)
Applicant MARINA MEDICAL INSTRUMENTS, INC.
1308 MORNINGSIDE PARK DR.
ALPHARETTA, GA 30022 US
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Contact JAY MANSOUR
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Regulation Number 884.1175

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Classification Product Code HHK
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Date Received 06/07/2002
Decision Date 04/08/2003
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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