The following data is part of a premarket notification filed by Thomas Industries with the FDA for Medi-pump Aspirator, Model 1615.
Device ID | K041199 |
510k Number | K041199 |
Device Name: | MEDI-PUMP ASPIRATOR, MODEL 1615 |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan, WI 53082 -0029 |
Contact | Daniel Pfister |
Correspondent | Daniel Pfister THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan, WI 53082 -0029 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-07 |
Decision Date | 2004-06-01 |
Summary: | summary |