The following data is part of a premarket notification filed by Zhejiang Kindly Medical Devices Co., Ltd with the FDA for Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles.
| Device ID | K171518 |
| 510k Number | K171518 |
| Device Name: | Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | Zhejiang Kindly Medical Devices Co., Ltd No.758, 5th Binhai Road, Binhai Industrial Park Longwan District Wenzhou, CN 325025 |
| Contact | Zenghua Zhang |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-24 |
| Decision Date | 2018-01-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850046230219 | K171518 | 000 |
| 00850046230202 | K171518 | 000 |
| 00850046230196 | K171518 | 000 |
| 00850046230189 | K171518 | 000 |
| 00850046230172 | K171518 | 000 |
| 00850046230165 | K171518 | 000 |
| 00850046230158 | K171518 | 000 |
| 00850046230141 | K171518 | 000 |