The following data is part of a premarket notification filed by Health Products, Inc. with the FDA for Metered Dose Inhaler (mdi) Spacer.
| Device ID | K911807 |
| 510k Number | K911807 |
| Device Name: | METERED DOSE INHALER (MDI) SPACER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HEALTH PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 |
| Contact | Lauren R Ziegler |
| Correspondent | Lauren R Ziegler HEALTH PRODUCTS, INC. 908 POMPTON AVE. UNIT B2 Cedar Grove, NJ 07009 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-23 |
| Decision Date | 1991-10-23 |