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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Circumcision
510(k) Number K926535
Device Name GOMCO CIRCUMCISION CLAMP
Applicant
Thomasville Medical Assoc.
935 Cobblestone Court
Alpharetta,  GA  30201
Applicant Contact THOMAS J ZINNANTI
Correspondent
Thomasville Medical Assoc.
935 Cobblestone Court
Alpharetta,  GA  30201
Correspondent Contact THOMAS J ZINNANTI
Regulation Number884.4530
Classification Product Code
HFX  
Date Received12/30/1992
Decision Date 02/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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