The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Customed Cardiovascular Pack.
| Device ID | K904693 |
| 510k Number | K904693 |
| Device Name: | CUSTOMED CARDIOVASCULAR PACK |
| Classification | Drape, Surgical |
| Applicant | CUSTOMED, INC. CALL BOX 158 Carolina Puerto Rico, |
| Contact | Jose M Negron |
| Correspondent | Jose M Negron CUSTOMED, INC. CALL BOX 158 Carolina Puerto Rico, |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-16 |
| Decision Date | 1991-01-02 |