The following data is part of a premarket notification filed by Thomas Industries with the FDA for Medi - Pump.
| Device ID | K950867 |
| 510k Number | K950867 |
| Device Name: | MEDI - PUMP |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | THOMAS INDUSTRIES 1419 ILLINOIS AVE. P.O. BOX 29 Sheboygan, WI 53082 -0029 |
| Contact | Dan Breitzman |
| Correspondent | Dan Breitzman THOMAS INDUSTRIES 1419 ILLINOIS AVE. P.O. BOX 29 Sheboygan, WI 53082 -0029 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-27 |
| Decision Date | 1995-04-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841447100225 | K950867 | 000 |