The following data is part of a premarket notification filed by Thomas Industries with the FDA for Medi Pump Aspirator Models 1130 And 1135.
Device ID | K952806 |
510k Number | K952806 |
Device Name: | MEDI PUMP ASPIRATOR MODELS 1130 AND 1135 |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
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 | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-19 |
Decision Date | 1995-10-26 |