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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 K923120
Device Name MICROGUIDE LESION MARKING SYSTEM
Applicant
Angiodynamics, Div. E-Z-Em, Inc.
P.O. 993
635 Big Boom Rd.
Glens Falls,  NY  12801
Applicant Contact MARLENE WRIGHT
Correspondent
Angiodynamics, Div. E-Z-Em, Inc.
P.O. 993
635 Big Boom Rd.
Glens Falls,  NY  12801
Correspondent Contact MARLENE WRIGHT
Regulation Number878.4800
Classification Product Code
GDF  
Date Received06/26/1992
Decision Date 09/01/1992
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
Predetermined Change
Control Plan Authorized		 No
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