The following data is part of a premarket notification filed by Biomate Medical Devices Technology Co., Ltd. with the FDA for Biomate Sterile Acupuncture Needle.
| Device ID | K103061 |
| 510k Number | K103061 |
| Device Name: | BIOMATE STERILE ACUPUNCTURE NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. NO.45, MINSHENG RD. DANSHUI TOWN Taipei County, TW 251 |
| Contact | Michael Lee |
| Correspondent | Michael Lee BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD. NO.45, MINSHENG RD. DANSHUI TOWN Taipei County, TW 251 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-18 |
| Decision Date | 2011-06-20 |