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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scissors For Cystoscope
510(k) Number K944054
Device Name POWDER FREE SURGEON'S GLOVE
Applicant
Arent Fox
1050 Connecticut Ave., NW
Washington,  DC  20036
Applicant Contact WAYNE H MATELSKI
Correspondent
Arent Fox
1050 Connecticut Ave., NW
Washington,  DC  20036
Correspondent Contact WAYNE H MATELSKI
Regulation Number876.1500
Classification Product Code
KGD  
Date Received08/19/1994
Decision Date 11/17/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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