The following data is part of a premarket notification filed by Lhasa Medical, Inc. with the FDA for Hua-xia Acupuncture Needles.
Device ID | K962916 |
510k Number | K962916 |
Device Name: | HUA-XIA ACUPUNCTURE NEEDLES |
Classification | Needle, Acupuncture, Single Use |
Applicant | LHASA MEDICAL, INC. 234 LIBBEY PKWY. Weymouth, MA 02189 |
Contact | Kyung P Riihimaki |
Correspondent | Kyung P 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 | 1996-07-26 |
Decision Date | 1996-08-23 |
Summary: | summary |