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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocautery, Gynecologic (And Accessories)
510(k) Number K993527
Device Name LOOP ELECTRODE, BALL ELECTRODE
Applicant
Palm Medical USA, Inc.
6322 NW 18th Dr., Suite 170
Gainesville,  FL  32653
Applicant Contact MARK J KAHN
Correspondent
Palm Medical USA, Inc.
6322 NW 18th Dr., Suite 170
Gainesville,  FL  32653
Correspondent Contact MARK J KAHN
Regulation Number884.4120
Classification Product Code
HGI  
Date Received10/18/1999
Decision Date 07/06/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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