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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name guide, needle, surgical
510(k) Number K920816
Device Name PERCUGUIDE LESION MARKING
Applicant
E-Z-EM, INC.
P.O. BOX 993
266 QUEENSBURY AVENUE
GLENS FALLS,  NY  12801
Applicant Contact MARLENE WRIGHT
Correspondent
E-Z-EM, INC.
P.O. BOX 993
266 QUEENSBURY AVENUE
GLENS FALLS,  NY  12801
Correspondent Contact MARLENE WRIGHT
Regulation Number878.4800
Classification Product Code
GDF  
Date Received02/06/1992
Decision Date 04/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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