The following data is part of a premarket notification filed by Apollon Co., Ltd. with the FDA for Foley Balloon Catheter For Urology.
| Device ID | K201776 |
| 510k Number | K201776 |
| Device Name: | Foley Balloon Catheter For Urology |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Apollon Co., Ltd. M-1804/3203, 32, Songdogwahak-ro, Yeonsu-gu Incheon, KR 21984 |
| Contact | Donghyuk Shin |
| Correspondent | Hyeyoung Moon TSD Life Sciences Co., Ltd. 211, Mallijae-ro, Jung-gu Seoul, KR 04508 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-29 |
| Decision Date | 2020-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800109200033 | K201776 | 000 |
| 18800109201563 | K201776 | 000 |
| 18800109201570 | K201776 | 000 |
| 18800109201587 | K201776 | 000 |
| 18800109201594 | K201776 | 000 |
| 18800109201600 | K201776 | 000 |
| 18800109201617 | K201776 | 000 |
| 18800109201624 | K201776 | 000 |
| 18800109201631 | K201776 | 000 |
| 18800109201532 | K201776 | 000 |
| 18800109201549 | K201776 | 000 |
| 08800109201528 | K201776 | 000 |
| 08800109201511 | K201776 | 000 |
| 18800109201556 | K201776 | 000 |