The following data is part of a premarket notification filed by Smc Intl., Inc. with the FDA for Smc Acupuncture Needle.
| Device ID | K141473 |
| 510k Number | K141473 |
| Device Name: | SMC ACUPUNCTURE NEEDLE |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | SMC INTL., INC. JISAN IT VENTURE CENTER 601 15, BEOTKKOT-RO 12-GIL, GEUMCHEON-GU Seoul, KR 153-289 |
| Contact | Jong-man Lee |
| Correspondent | Jong-man Lee SMC INTL., INC. JISAN IT VENTURE CENTER 601 15, BEOTKKOT-RO 12-GIL, GEUMCHEON-GU Seoul, KR 153-289 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-03 |
| Decision Date | 2014-08-01 |
| Summary: | summary |