The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex Intermittent Catheters, Male, Female, Pediatric.
| Device ID | K103086 |
| 510k Number | K103086 |
| Device Name: | DYNAREX INTERMITTENT CATHETERS, MALE, FEMALE, PEDIATRIC |
| Classification | Catheter, Straight |
| Applicant | DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Contact | Daniel Consaga |
| Correspondent | Daniel Consaga DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-19 |
| Decision Date | 2011-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784499536 | K103086 | 000 |
| 00616784498232 | K103086 | 000 |
| 00616784498331 | K103086 | 000 |
| 00616784498430 | K103086 | 000 |
| 00616784498539 | K103086 | 000 |
| 00616784498638 | K103086 | 000 |
| 00616784499130 | K103086 | 000 |
| 00616784499239 | K103086 | 000 |
| 00616784499338 | K103086 | 000 |
| 00616784499437 | K103086 | 000 |
| 00616784498133 | K103086 | 000 |