The following data is part of a premarket notification filed by Woojeon Company with the FDA for Woojeon Acupuncture Needle (=sera Acupuncture Needle).
| Device ID | K111392 |
| 510k Number | K111392 |
| Device Name: | WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE) |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | WOOJEON COMPANY 300 ATWOOD Pittsburgh, PA 15213 |
| Contact | Peter Chung |
| Correspondent | Peter Chung WOOJEON COMPANY 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-18 |
| Decision Date | 2011-11-04 |
| Summary: | summary |