The following data is part of a premarket notification filed by Sherwood Medical Co. with the FDA for Argyle Rob-nels.
| Device ID | K810216 |
| 510k Number | K810216 |
| Device Name: | ARGYLE ROB-NELS |
| Classification | Catheter, Urological |
| Applicant | SHERWOOD MEDICAL CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-01-27 |
| Decision Date | 1981-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521009018 | K810216 | 000 |
| 10884521050693 | K810216 | 000 |
| 10884521050709 | K810216 | 000 |
| 10884521050716 | K810216 | 000 |
| 10884521050723 | K810216 | 000 |
| 10884521050730 | K810216 | 000 |
| 20884521008806 | K810216 | 000 |
| 20884521008820 | K810216 | 000 |
| 20884521008875 | K810216 | 000 |
| 20884521008905 | K810216 | 000 |
| 20884521008912 | K810216 | 000 |
| 20884521008936 | K810216 | 000 |
| 20884521008943 | K810216 | 000 |
| 20884521008950 | K810216 | 000 |
| 20884521008967 | K810216 | 000 |
| 20884521008974 | K810216 | 000 |
| 20884521008981 | K810216 | 000 |
| 20884521008998 | K810216 | 000 |
| 10884521050686 | K810216 | 000 |