The following data is part of a premarket notification filed by Shanghai Sa Medical & Plastic Instruments Co., Ltd with the FDA for Anesthesia Conduction Needles.
| Device ID | K120475 |
| 510k Number | K120475 |
| Device Name: | ANESTHESIA CONDUCTION NEEDLES |
| Classification | Needle, Conduction, Anesthetic (w/wo Introducer) |
| Applicant | SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD 7TH FL, JINGUI BUSINESS BLDG. NO. 982 CONGYUM RD Baiyum District, Guangzhou, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu SHANGHAI SA MEDICAL & PLASTIC INSTRUMENTS CO., LTD 7TH FL, JINGUI BUSINESS BLDG. NO. 982 CONGYUM RD Baiyum District, Guangzhou, CN 510420 |
| Product Code | BSP |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-16 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06955741822623 | K120475 | 000 |
| 06955741823316 | K120475 | 000 |
| 06955741822241 | K120475 | 000 |
| 06955741822289 | K120475 | 000 |
| 06955741822340 | K120475 | 000 |
| 06955741822364 | K120475 | 000 |
| 06955741822388 | K120475 | 000 |
| 06955741822401 | K120475 | 000 |
| 06955741822562 | K120475 | 000 |
| 06955741822586 | K120475 | 000 |
| 06955741822609 | K120475 | 000 |
| 06955741821466 | K120475 | 000 |