The following data is part of a premarket notification filed by Aplan Well Enterprise Co., Ltd with the FDA for Aplan A.v. Fistula Needle Set.
| Device ID | K112734 |
| 510k Number | K112734 |
| Device Name: | APLAN A.V. FISTULA NEEDLE SET |
| Classification | Needle, Fistula |
| Applicant | APLAN WELL ENTERPRISE CO., LTD NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min APLAN WELL ENTERPRISE CO., LTD NO. 58, FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | FIE |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-20 |
| Decision Date | 2012-04-24 |
| Summary: | summary |