FDA 510(k) Application Details - K993527

Device Classification Name Electrocautery, Gynecologic (And Accessories)

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510(K) Number K993527
Device Name Electrocautery, Gynecologic (And Accessories)
Applicant PALM MEDICAL USA, INC.
6322 N.W. 18TH DR., SUITE 170
GAINESVILLE, FL 32653 US
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Contact MARK J KAHN
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Regulation Number 884.4120

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Classification Product Code HGI
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Date Received 10/18/1999
Decision Date 07/06/2000
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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