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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mammographic
510(k) Number K933430
Device Name CYTOGUIDE STEREOTATIC BIOPSY SYSTEM
Applicant
Gold Coast Imaging, Inc.
6555 NW 9th Ave.,
Suite 211
Ft. Lauderdale,  FL  33309
Applicant Contact EDWARD C CHEEK
Correspondent
Gold Coast Imaging, Inc.
6555 NW 9th Ave.,
Suite 211
Ft. Lauderdale,  FL  33309
Correspondent Contact EDWARD C CHEEK
Regulation Number892.1710
Classification Product Code
IZH  
Date Received07/13/1993
Decision Date 09/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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