The following data is part of a premarket notification filed by Thomas Industries with the FDA for Cpi, Maxi-vac(6480),thomas Industries, Medi-pump(1240/1242/1243).
Device ID | K965059 |
510k Number | K965059 |
Device Name: | CPI, MAXI-VAC(6480),THOMAS INDUSTRIES, MEDI-PUMP(1240/1242/1243) |
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 | 1996-12-18 |
Decision Date | 1997-03-04 |