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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coagulator, Culdoscopic (And Accessories)
510(k) Number K924148
Device Name DIAMOND-SHARP(R) TROCARS
Applicant
Snowden-Pencer
5175 S. Royal Atlanta Dr.
Tucker,  GA  30084
Applicant Contact JULIE A STEPHENS
Correspondent
Snowden-Pencer
5175 S. Royal Atlanta Dr.
Tucker,  GA  30084
Correspondent Contact JULIE A STEPHENS
Regulation Number884.4160
Classification Product Code
HFI  
Date Received08/18/1992
Decision Date 02/28/1994
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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