The following data is part of a premarket notification filed by Seirin-america, Inc. with the FDA for Seirin Spinex Intradermal Acupuncture Needles.
| Device ID | K963769 |
| 510k Number | K963769 |
| Device Name: | SEIRIN SPINEX INTRADERMAL ACUPUNCTURE NEEDLES |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | SEIRIN-AMERICA, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Thomas Riihimaki |
| Correspondent | Thomas Riihimaki SEIRIN-AMERICA, INC. 230 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 | 1996-09-19 |
| Decision Date | 1996-10-16 |
| Summary: | summary |