The following data is part of a premarket notification filed by Suzhou Sen Sen Medical Supplies Ltd. with the FDA for Carbo/optimed Brand Acupuncture Needles.
| Device ID | K030190 |
| 510k Number | K030190 |
| Device Name: | CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | SUZHOU SEN SEN MEDICAL SUPPLIES LTD. 4500 SHEPPARD AVE. EAST UNIT #1, SCARBOROUGH Ontario, CA |
| Contact | Kevin Liu |
| Correspondent | Kevin Liu SUZHOU SEN SEN MEDICAL SUPPLIES LTD. 4500 SHEPPARD AVE. EAST UNIT #1, SCARBOROUGH Ontario, CA |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-02-21 |
| Summary: | summary |