The following data is part of a premarket notification filed by Customed, Inc. with the FDA for Urinary Drainage Bag, (reorder No. 0749 - Product No. 900-749).
| Device ID | K962652 |
| 510k Number | K962652 |
| Device Name: | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| 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 | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-08 |
| Decision Date | 1996-10-04 |