The following data is part of a premarket notification filed by Hansol Medical Co. with the FDA for Hanso Acupuncture Needle.
| Device ID | K090910 |
| 510k Number | K090910 |
| Device Name: | HANSO ACUPUNCTURE NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | HANSOL MEDICAL CO. 300 ATWOOD ST. Pittsburgh, PA 15213 |
| Contact | Peter Chun |
| Correspondent | Peter Chun HANSOL MEDICAL CO. 300 ATWOOD ST. 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 | 2009-04-01 |
| Decision Date | 2009-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809118710939 | K090910 | 000 |
| 08809118710410 | K090910 | 000 |
| 08809118710397 | K090910 | 000 |
| 08809118710298 | K090910 | 000 |
| 08809118710274 | K090910 | 000 |
| 08809118710250 | K090910 | 000 |
| 08809118710236 | K090910 | 000 |
| 08809118710212 | K090910 | 000 |
| 08809118710113 | K090910 | 000 |
| 08809118710090 | K090910 | 000 |
| 08809118710076 | K090910 | 000 |
| 08809118710052 | K090910 | 000 |
| 08809118710434 | K090910 | 000 |
| 08809118710458 | K090910 | 000 |
| 08809118710830 | K090910 | 000 |
| 08809118710816 | K090910 | 000 |
| 08809118710793 | K090910 | 000 |
| 08809118710779 | K090910 | 000 |
| 08809118710755 | K090910 | 000 |
| 08809118710656 | K090910 | 000 |
| 08809118710632 | K090910 | 000 |
| 08809118710618 | K090910 | 000 |
| 08809118710595 | K090910 | 000 |
| 08809118710571 | K090910 | 000 |
| 08809118710472 | K090910 | 000 |
| 08809118710038 | K090910 | 000 |