The following data is part of a premarket notification filed by Lhasa Medical, Inc. with the FDA for Cw Acupuncture Needles.
| Device ID | K964529 |
| 510k Number | K964529 |
| Device Name: | CW ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | LHASA MEDICAL, INC. 234 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Kyung Soon Riihimaki |
| Correspondent | Kyung Soon Riihimaki LHASA MEDICAL, INC. 234 LIBBEY PKWY. Weymouth, MA 02189 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-01-30 |
| Summary: | summary |