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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
Other 510(k) Applications for this Contact
Regulation Number
884.4120
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Classification Product Code
HGI
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More FDA Info for this Product Code
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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