The following data is part of a premarket notification filed by Flexicare Medical Ltd. with the FDA for Classic Intermittent Catheter.
| Device ID | K132619 |
| 510k Number | K132619 |
| Device Name: | CLASSIC INTERMITTENT CATHETER |
| Classification | Catheter, Straight |
| Applicant | FLEXICARE MEDICAL LTD. CYNON VALLEY BUSINESS PARK MOUTAIN ASH Mid Glamorgan, GB Cf45 4er |
| Contact | Christopher Watkins |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2013-08-21 |
| Decision Date | 2013-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788710608 | K132619 | 000 |
| 05055788710431 | K132619 | 000 |
| 05055788710448 | K132619 | 000 |
| 05055788710455 | K132619 | 000 |
| 05055788710462 | K132619 | 000 |
| 05055788710479 | K132619 | 000 |
| 05055788710486 | K132619 | 000 |
| 05055788710493 | K132619 | 000 |
| 05055788710509 | K132619 | 000 |
| 05055788710516 | K132619 | 000 |
| 05055788710523 | K132619 | 000 |
| 05055788710530 | K132619 | 000 |
| 05055788710547 | K132619 | 000 |
| 05055788710554 | K132619 | 000 |
| 05055788710561 | K132619 | 000 |
| 05055788710578 | K132619 | 000 |
| 05055788710585 | K132619 | 000 |
| 05055788710592 | K132619 | 000 |
| 05055788710424 | K132619 | 000 |