The following data is part of a premarket notification filed by Thomas Industries with the FDA for Medi - Pump.
Device ID | K951729 |
510k Number | K951729 |
Device Name: | MEDI - PUMP |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan, WI 53082 -0029 |
Contact | Dan P Fister |
Correspondent | Dan P Fister THOMAS INDUSTRIES 1419 ILLINOIS AVE. Sheboygan, WI 53082 -0029 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-14 |
Decision Date | 1995-08-21 |