The following data is part of a premarket notification filed by Glaxo, Inc. with the FDA for Syringe Needle Introducer.
| Device ID | K901803 |
| 510k Number | K901803 |
| Device Name: | SYRINGE NEEDLE INTRODUCER |
| Classification | Introducer, Syringe Needle |
| Applicant | GLAXO, INC. 5 MOORE DR. P.O. BOX 13358 Research Triangle, NC 27709 |
| Contact | James E Murray |
| Correspondent | James E Murray GLAXO, INC. 5 MOORE DR. P.O. BOX 13358 Research Triangle, NC 27709 |
| Product Code | KZH |
| CFR Regulation Number | 880.6920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-19 |
| Decision Date | 1990-11-20 |