The following data is part of a premarket notification filed by Weihai Jierui Medical Products Co., Ltd. with the FDA for I.v. Catheter, Models: Type I, Type Y, Type Straight.
| Device ID | K083429 |
| 510k Number | K083429 |
| Device Name: | I.V. CATHETER, MODELS: TYPE I, TYPE Y, TYPE STRAIGHT |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. STE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. STE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-19 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10814639026273 | K083429 | 000 |
| 10814639026266 | K083429 | 000 |
| 10814639026259 | K083429 | 000 |
| 10814639026242 | K083429 | 000 |
| 10814639026235 | K083429 | 000 |