The following data is part of a premarket notification filed by Care Wise Medical Products Corp. with the FDA for Oncoprobe Ii System.
| Device ID | K896588 |
| 510k Number | K896588 |
| Device Name: | ONCOPROBE II SYSTEM |
| Classification | Probe, Uptake, Nuclear |
| Applicant | CARE WISE MEDICAL PRODUCTS CORP. P.O. BOX 1655 Morgan Hill, CA 95038 -1655 |
| Contact | Linda P Carroll,phd |
| Correspondent | Linda P Carroll,phd 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 | 1989-11-21 |
| Decision Date | 1990-03-14 |