The following data is part of a premarket notification filed by Glaxo, Inc. with the FDA for Compact Spacer.
| Device ID | K922187 |
| 510k Number | K922187 |
| Device Name: | COMPACT SPACER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | GLAXO, INC. 5 MOORE DR. P.O. BOX 13358 Research Triangle, NC 27709 |
| Contact | Thomas A Gerding |
| Correspondent | Thomas A Gerding GLAXO, INC. 5 MOORE DR. P.O. BOX 13358 Research Triangle, NC 27709 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-11 |
| Decision Date | 1992-11-20 |