The following data is part of a premarket notification filed by Medionics International, Inc. with the FDA for Faller Stylet.
| Device ID | K130441 |
| 510k Number | K130441 |
| Device Name: | FALLER STYLET |
| Classification | Catheter, Peritoneal, Long-term Indwelling |
| Applicant | MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Contact | Mahesh Agarwal |
| Correspondent | Mahesh Agarwal MEDIONICS INTERNATIONAL, INC. 114 ANDERSON AVE. Markham, Ontario, CA L6e 1a5 |
| Product Code | FJS |
| CFR Regulation Number | 876.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-21 |
| Decision Date | 2013-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00792079001223 | K130441 | 000 |
| 00792079001216 | K130441 | 000 |
| 00792079000424 | K130441 | 000 |