The following data is part of a premarket notification filed by Medical/surgical Specialties, Ltd. with the FDA for Cardicad(tm).
| Device ID | K881392 |
| 510k Number | K881392 |
| Device Name: | CARDICAD(TM) |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | MEDICAL/SURGICAL SPECIALTIES, LTD. 1611 W. CENTRE ST. Kalamazoo, MI 49002 |
| Contact | James L Phillips |
| Correspondent | James L Phillips MEDICAL/SURGICAL SPECIALTIES, LTD. 1611 W. CENTRE ST. Kalamazoo, MI 49002 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-05-31 |