The following data is part of a premarket notification filed by Glaxo, Inc. with the FDA for G.r.e.e.n. Disposal Container (note: G.r.e.e.n. Is An Acronym For Glaxo Retrieval Effort For Expended Needles).
| Device ID | K954041 |
| 510k Number | K954041 |
| Device Name: | G.R.E.E.N. DISPOSAL CONTAINER (NOTE: G.R.E.E.N. IS AN ACRONYM FOR GLAXO RETRIEVAL EFFORT FOR EXPENDED NEEDLES) |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | GLAXO, INC. FIVE MOORE DR. Research Triangle Park, NC 27709 |
| Contact | James E Murray |
| Correspondent | James E Murray GLAXO, INC. FIVE MOORE DR. Research Triangle Park, NC 27709 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-29 |
| Decision Date | 1995-10-16 |