The following data is part of a premarket notification filed by Care Wise Medical Products Corp. with the FDA for C-trak Biopsy System.
| Device ID | K922117 |
| 510k Number | K922117 |
| Device Name: | C-TRAK BIOPSY SYSTEM |
| Classification | Probe, Uptake, Nuclear |
| Applicant | CARE WISE MEDICAL PRODUCTS CORP. P.O. BOX 1655 Morgan Hill, CA 95038 -1655 |
| Contact | Wise, Jr. |
| Correspondent | Wise, Jr. CARE WISE MEDICAL PRODUCTS CORP. P.O. BOX 1655 Morgan Hill, CA 95038 -1655 |
| Product Code | IZD |
| CFR Regulation Number | 892.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-05 |
| Decision Date | 1992-10-14 |