The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Intertech/inspiron (r) Medication Nebulizer Kit.
| Device ID | K896923 |
| 510k Number | K896923 |
| Device Name: | INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | James Pope |
| Correspondent | James Pope INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-12-12 |
| Decision Date | 1990-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30351688410355 | K896923 | 000 |
| 30351688403036 | K896923 | 000 |