The following data is part of a premarket notification filed by C.a.i. Industries Corp. with the FDA for Acupuncture Needles.
| Device ID | K970574 |
| 510k Number | K970574 |
| Device Name: | ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | C.A.I. INDUSTRIES CORP. 800 SOUTH PALM AVE. SUITE 10 Alhambra, CA 91803 |
| Contact | Lu Rao |
| Correspondent | Lu Rao C.A.I. INDUSTRIES CORP. 800 SOUTH PALM AVE. SUITE 10 Alhambra, CA 91803 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-13 |
| Decision Date | 1997-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00807689100843 | K970574 | 000 |
| 00807689100546 | K970574 | 000 |
| 00807689100539 | K970574 | 000 |
| 00807689100522 | K970574 | 000 |
| 00807689100515 | K970574 | 000 |
| 00807689100430 | K970574 | 000 |
| 00807689100423 | K970574 | 000 |
| 00807689100416 | K970574 | 000 |
| 00807689100324 | K970574 | 000 |
| 00807689100614 | K970574 | 000 |
| 00807689100621 | K970574 | 000 |
| 00807689100638 | K970574 | 000 |
| 00807689100836 | K970574 | 000 |
| 00807689100829 | K970574 | 000 |
| 00807689100812 | K970574 | 000 |
| 00807689100744 | K970574 | 000 |
| 00807689100737 | K970574 | 000 |
| 00807689100720 | K970574 | 000 |
| 00807689100713 | K970574 | 000 |
| 00807689100645 | K970574 | 000 |
| 00807689100317 | K970574 | 000 |