The following data is part of a premarket notification filed by Respiratory Delivery Systems, Inc. with the FDA for Microspacer Tm.
| Device ID | K903413 |
| 510k Number | K903413 |
| Device Name: | MICROSPACER TM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | RESPIRATORY DELIVERY SYSTEMS, INC. 70 MOUNT HOPE ST. Lowell, MA 01854 |
| Contact | Makiej Jr. |
| Correspondent | Makiej Jr. RESPIRATORY DELIVERY SYSTEMS, INC. 70 MOUNT HOPE ST. Lowell, MA 01854 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-07-30 |
| Decision Date | 1990-10-09 |