The following data is part of a premarket notification filed by Cure Medical Llc. with the FDA for Cure Catheter Closed System.
| Device ID | K080881 |
| 510k Number | K080881 |
| Device Name: | CURE CATHETER CLOSED SYSTEM |
| Classification | Catheter, Urological |
| Applicant | CURE MEDICAL LLC. 29442 POINTE ROYAL Laguna Niguel, CA 92677 |
| Contact | James Smith |
| Correspondent | Casey Conry UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | Yes |
| Date Received | 2008-03-31 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815947020656 | K080881 | 000 |
| 20815947021087 | K080881 | 000 |
| 00815947021243 | K080881 | 000 |
| 10815947021257 | K080881 | 000 |
| 10815947021264 | K080881 | 000 |
| 00815947020369 | K080881 | 000 |
| 20815947020370 | K080881 | 000 |
| 20815947020387 | K080881 | 000 |
| 20815947020394 | K080881 | 000 |
| 20815947021070 | K080881 | 000 |
| 20815947021063 | K080881 | 000 |
| 20815947020417 | K080881 | 000 |
| 20815947020424 | K080881 | 000 |
| 20815947020431 | K080881 | 000 |
| 20815947020448 | K080881 | 000 |
| 20815947020455 | K080881 | 000 |
| 20815947021032 | K080881 | 000 |
| 20815947021049 | K080881 | 000 |
| 20815947021056 | K080881 | 000 |
| 20815947020400 | K080881 | 000 |
| 20815947020509 | K080881 | 000 |
| 20815947020516 | K080881 | 000 |
| 20815947020943 | K080881 | 000 |
| 20815947020950 | K080881 | 000 |
| 20815947020967 | K080881 | 000 |
| 20815947020974 | K080881 | 000 |
| 00815947021335 | K080881 | 000 |
| 00815947021342 | K080881 | 000 |
| 00815947021366 | K080881 | 000 |
| 00815947021373 | K080881 | 000 |
| 10815947020694 | K080881 | 000 |
| 10815947020687 | K080881 | 000 |
| 10815947020588 | K080881 | 000 |
| 10815947020595 | K080881 | 000 |
| 00815947020604 | K080881 | 000 |
| 10815947020618 | K080881 | 000 |
| 10815947020625 | K080881 | 000 |
| 10815947020649 | K080881 | 000 |
| 10815947020663 | K080881 | 000 |
| 10815947020670 | K080881 | 000 |
| 00815947021380 | K080881 | 000 |