The following data is part of a premarket notification filed by Yomura Technologies Inc. with the FDA for Yomura Safety I.v. Catheter.
| Device ID | K112542 |
| 510k Number | K112542 |
| Device Name: | YOMURA SAFETY I.V. CATHETER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | YOMURA TECHNOLOGIES INC. NO. 2-3, KUNG 8TH ROAD SECOND INDUSTRIAL PARK New Taipei City, TW 244 |
| Contact | Sherry Lin |
| Correspondent | Sherry Lin YOMURA TECHNOLOGIES INC. NO. 2-3, KUNG 8TH ROAD SECOND INDUSTRIAL PARK New Taipei City, TW 244 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-02-08 |
| Summary: | summary |