The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Customed Cysto Pack Ii.
| Device ID | K901705 |
| 510k Number | K901705 |
| Device Name: | CUSTOMED CYSTO PACK II |
| Classification | Drape, Surgical |
| Applicant | CUSTOMED, INC. CALL BOX 158 Carolina Puerto Rico, |
| Contact | Felix B Santos |
| Correspondent | Felix B Santos CUSTOMED, INC. CALL BOX 158 Carolina Puerto Rico, |
| Product Code | KKX |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-12 |
| Decision Date | 1990-10-31 |