The following data is part of a premarket notification filed by K.m.s. Inc. with the FDA for Km Needles (acupuncture Needle).
| Device ID | K142920 |
| 510k Number | K142920 |
| Device Name: | KM Needles (Acupuncture Needle) |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | K.M.S. INC. F2, 81-1 HAENFJEONG-RI, GWANGDEOK-MYEON, DONGNAM-GU Cheonan-si, KR 330922 |
| Contact | Chul Hui Kim |
| Correspondent | Charlie Mack International Regulatory Consulting 12226 Washington Lane Parker, AZ 85344 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-08 |
| Decision Date | 2015-06-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38800020500169 | K142920 | 000 |
| 38800020500015 | K142920 | 000 |
| 38800020500022 | K142920 | 000 |
| 38800020500039 | K142920 | 000 |
| 38800020500046 | K142920 | 000 |
| 38800020500053 | K142920 | 000 |
| 38800020500060 | K142920 | 000 |
| 38800020500077 | K142920 | 000 |
| 38800020500084 | K142920 | 000 |
| 38800020500091 | K142920 | 000 |
| 38800020500107 | K142920 | 000 |
| 38800020500114 | K142920 | 000 |
| 38800020500121 | K142920 | 000 |
| 38800020500138 | K142920 | 000 |
| 38800020500145 | K142920 | 000 |
| 38800020500152 | K142920 | 000 |
| 38800020500008 | K142920 | 000 |