The following data is part of a premarket notification filed by Cure Medical Llc. with the FDA for Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated.
| Device ID | K132500 |
| 510k Number | K132500 |
| Device Name: | CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED |
| Classification | Catheter, Straight |
| Applicant | CURE MEDICAL LLC. 257 GARNET GARDEN STREET Henderson, NV 89015 |
| Contact | John Beasley |
| Correspondent | John Beasley CURE MEDICAL LLC. 257 GARNET GARDEN STREET Henderson, NV 89015 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-09 |
| Decision Date | 2013-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20815947021223 | K132500 | 000 |
| 20815947020301 | K132500 | 000 |
| 20815947020318 | K132500 | 000 |
| 20815947020325 | K132500 | 000 |
| 00815947020338 | K132500 | 000 |
| 20815947020349 | K132500 | 000 |
| 20815947020356 | K132500 | 000 |
| 20815947020998 | K132500 | 000 |
| 20815947021001 | K132500 | 000 |
| 20815947021018 | K132500 | 000 |
| 20815947020981 | K132500 | 000 |