The following data is part of a premarket notification filed by Gold Coast Imaging, Inc. with the FDA for Cytoguide Stereotatic Biopsy System.
| Device ID | K933430 |
| 510k Number | K933430 |
| Device Name: | CYTOGUIDE STEREOTATIC BIOPSY SYSTEM |
| Classification | System, X-ray, Mammographic |
| Applicant | GOLD COAST IMAGING, INC. 6555 N.W. 9TH AVENUE, SUITE 211 Ft. Lauderdale, FL 33309 |
| Contact | Edward C Cheek |
| Correspondent | Edward C Cheek GOLD COAST IMAGING, INC. 6555 N.W. 9TH AVENUE, SUITE 211 Ft. Lauderdale, FL 33309 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-13 |
| Decision Date | 1994-09-22 |