The following data is part of a premarket notification filed by Aeros Instruments, Inc. with the FDA for Tote-l-vac.
Device ID | K932051 |
510k Number | K932051 |
Device Name: | TOTE-L-VAC |
Classification | Pump, Portable, Aspiration (manual Or Powered) |
Applicant | AEROS INSTRUMENTS, INC. 3411 COMMERCIAL AVE. Northbrook, IL 60062 |
Contact | Chris Gossett |
Correspondent | Chris Gossett AEROS INSTRUMENTS, INC. 3411 COMMERCIAL AVE. Northbrook, IL 60062 |
Product Code | BTA |
CFR Regulation Number | 878.4780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-04-27 |
Decision Date | 1993-11-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08688250002405 | K932051 | 000 |
00628101609320 | K932051 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() TOTE-L-VAC 74310693 1863115 Live/Registered |
OHIO MEDICAL CORPORATION 1992-09-02 |