The following data is part of a premarket notification filed by Prime Herbs Corporation with the FDA for Precision Press Tack / Intraderm, Seven Star And Acupuncture Needles; Alpha And Fine Point Acupuncture Needles.
| Device ID | K061517 |
| 510k Number | K061517 |
| Device Name: | PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | PRIME HERBS CORPORATION 754 SAN ALESO AVE. Sunnyvale, CA 94085 |
| Contact | Genevieve Hsia |
| Correspondent | Genevieve Hsia PRIME HERBS CORPORATION 754 SAN ALESO AVE. Sunnyvale, CA 94085 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-01 |
| Decision Date | 2006-11-22 |
| Summary: | summary |