The following data is part of a premarket notification filed by Medi-sharp, Inc. with the FDA for C.a.b. Ring.
| Device ID | K894268 |
| 510k Number | K894268 |
| Device Name: | C.A.B. RING |
| Classification | Marker, Cardiopulmonary Bypass (vein Marker) |
| Applicant | MEDI-SHARP, INC. P.O. BOX 1864 Stafford, TX 77497 -1864 |
| Contact | A.l Martin |
| Correspondent | A.l Martin MEDI-SHARP, INC. P.O. BOX 1864 Stafford, TX 77497 -1864 |
| Product Code | MAB |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-22 |
| Decision Date | 1989-08-17 |