The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgiteks Percutaneous Antegrade All -.
| Device ID | K830884 |
| 510k Number | K830884 |
| Device Name: | SURGITEKS PERCUTANEOUS ANTEGRADE ALL - |
| Classification | Stent, Ureteral |
| Applicant | MEDICAL ENGINEERING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925007147 | K830884 | 000 |
| 00821925004245 | K830884 | 000 |
| 00821925004238 | K830884 | 000 |
| 00821925004221 | K830884 | 000 |
| 00821925004122 | K830884 | 000 |
| 00821925003705 | K830884 | 000 |
| 00821925003552 | K830884 | 000 |
| 00821925002845 | K830884 | 000 |
| 00821925002609 | K830884 | 000 |
| 00821925001459 | K830884 | 000 |
| 00821925001206 | K830884 | 000 |
| 00821925001169 | K830884 | 000 |
| 00821925004252 | K830884 | 000 |
| 00821925004269 | K830884 | 000 |
| 00821925006966 | K830884 | 000 |
| 00821925006942 | K830884 | 000 |
| 00821925006744 | K830884 | 000 |
| 00821925006348 | K830884 | 000 |
| 00821925005143 | K830884 | 000 |
| 00821925004658 | K830884 | 000 |
| 00821925004641 | K830884 | 000 |
| 00821925004559 | K830884 | 000 |
| 00821925004474 | K830884 | 000 |
| 00821925004429 | K830884 | 000 |
| 00821925004276 | K830884 | 000 |
| 00821925001152 | K830884 | 000 |