FDA 510(k) Application Details - K973671

Device Classification Name Set, Anesthesia, Paracervical

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510(K) Number K973671
Device Name Set, Anesthesia, Paracervical
Applicant A & A MEDICAL, INC.
4100 NINE MCFARLAND DR., #B
ALPHARETTA, GA 30201 US
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Contact JIHAD MANSOUR
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Regulation Number 884.5100

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Classification Product Code HEE
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Date Received 09/26/1997
Decision Date 11/26/1997
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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