The following data is part of a premarket notification filed by Instrumentation Industries, Inc. with the FDA for Metered Dose Inhaler Adapter-disposable, Adapter Reusable.
| Device ID | K991355 |
| 510k Number | K991355 |
| Device Name: | METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Contact | Tricia Wood |
| Correspondent | Tricia Wood INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. Bethel Park, PA 15102 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-19 |
| Decision Date | 2000-01-27 |