The following data is part of a premarket notification filed by Thomas Industries with the FDA for Medi - Pump.
Device ID | K950290 |
510k Number | K950290 |
Device Name: | MEDI - PUMP |
Classification | Nebulizer (direct Patient Interface) |
Applicant | THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan, WI 53082 -0029 |
Contact | Dan Pfister |
Correspondent | Dan Pfister THOMAS INDUSTRIES 1419 ILLINOIS AVE. 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 | 1995-01-25 |
Decision Date | 1995-08-24 |