The following data is part of a premarket notification filed by Ideal Medical, Inc. with the FDA for Contour-port.
| Device ID | K912540 |
| 510k Number | K912540 |
| Device Name: | CONTOUR-PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Lorna K Linville |
| Correspondent | Lorna K Linville IDEAL MEDICAL, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-10 |
| Decision Date | 1991-08-23 |