The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Customed Cysto Pack I.
| Device ID | K902274 |
| 510k Number | K902274 |
| Device Name: | CUSTOMED CYSTO PACK I |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | CUSTOMED, INC. BOX 7699 CAROLINA Puerto Rico, |
| Contact | Felix B Santos |
| Correspondent | Felix B Santos CUSTOMED, INC. BOX 7699 CAROLINA Puerto Rico, |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-21 |
| Decision Date | 1990-09-20 |