The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Suction Catheter Tray Product No. 900277.
| Device ID | K964011 |
| 510k Number | K964011 |
| Device Name: | SUCTION CATHETER TRAY PRODUCT NO. 900277 |
| Classification | General Surgery Tray |
| Applicant | CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Contact | Osvaldo Rodriguez |
| Correspondent | Osvaldo Rodriguez CUSTOMED, INC. CALLE IGUALDAD #7 Fajardo, PR 00738 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1996-11-25 |